Cediranib Maleate and Olaparib or Standard Chemotherapy in Treating Patients with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Status: Active

Description

This randomized phase II / III trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned (recurrent) after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Patients must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of either serous or endometrioid cancer based on local histopathological findings; both endometrioid and serous histology should be high-grade for eligibility of non-mutation carriers; patients with clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory * Note: Due to the long acceptance of BRCA testing through Myriad, Myriad testing will be accepted; if testing for BRCA is done by other organizations, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) listing the mutation and confirming that the laboratory results showed a recognized germ line deleterious BRCA 1 or BRCA 2 mutation or BRCA rearrangement is required; a copy of Myriad or other BRCA mutational analysis (positive or variants of unknown significance [VUS] or negative) reports will be requested but not required for study enrollment
  • Patients should have recurrent platinum-resistant or- refractory disease - defined as disease that has progressed by imaging while receiving platinum or had recurrence within 6 months of the last receipt of platinum-based chemotherapy; rising CA125 only is not considered as platinum-resistant or refractory disease
  • Phase II study: measurable disease by RECIST 1.1 criteria; if archival tumor sample is not available tumor sample from fresh biopsy is acceptable
  • Phase III study: evaluable disease - defined as RECIST 1.1 measurable disease OR non-measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related in the setting of a cancer antigen [CA]125 >= 2 x upper limit of normal [ULN])
  • No more than 3 prior treatment regimens (including primary therapy; no more than 1 prior non-platinum based therapy in the platinum-resistant/-refractory setting); hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will not count towards this line limit
  • Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed
  • Patients may not have previously received a PARP-inhibitor
  • Patient must have provided study specific informed consent prior to study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 10 g/dL
  • Total bilirubin within =< 1.5 times the upper limit of normal (ULN) institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN; if intrahepatic liver metastases are present, AST and ALT must be =< 5 times institutional ULN
  • Creatinine =< 1.5 x the institutional ULN
  • Urine protein: creatinine ratio urine protein creatinine (UPC) of =< 1 OR less than or equal to 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart; UPC is the preferred test; patients with 2+ proteinuria on dipstick must also have a 24-hour urine collection demonstrating protein of =< 500 mg over 24 hours
  • Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the study chair.
  • Adequately controlled blood pressure (systolic blood pressure [SBP] =< 140; diastolic blood pressure [DBP] =< 90 mmHg) on maximum of three antihypertensive medications; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; it is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or a primary care physician for management of BP while on protocol; patients must be willing and able to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients randomized to cediranib alone and the combination of olaparib and cediranib arms.
  • Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid-stimulating hormone (TSH) within normal limits
  • Able to swallow and retain oral medications and without gastrointestinal (GI) illnesses that would preclude absorption of cediranib or olaparib
  • Cediranib has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 weeks after cediranib discontinuation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Olaparib adversely affects embryofetal survival and development in the rat; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after the last dose of olaparib; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Exclusion Criteria

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients may not have had hormonal therapy within 2 weeks prior to entering the study; patients receiving raloxifene for bone health as per Food and Drug Administration (FDA) indication may remain on raloxifene absent other drug interactions
  • Any other investigational agents within the past 4 weeks
  • Prior treatment affecting the VEGF/VEGFR pathway or the angiopoietin pathway in the recurrent setting, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, pazopanib, cediranib, nintedanib, and trebananib; bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed
  • Prior use of PARP-inhibitors
  • CA-125 only disease without Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable or otherwise evaluable disease
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib
  • Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
  • History of intra-abdominal abscess within the past 3 months
  • History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula
  • Dependency on IV hydration or total parenteral nutrition (TPN)
  • Any concomitant or prior invasive malignancies with the following curatively treated exceptions: * Treated limited stage basal cell or squamous cell carcinoma of the skin * Carcinoma in situ of the breast or cervix * Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions * Prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence
  • Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug
  • Patients with any of the following: * History of myocardial infarction within six months * Unstable angina * Resting electrocardiogram (ECG) with clinically significant abnormal findings * New York Heart Association functional classification of III or IV
  • If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines * Patients with the following risk factors should have a baseline cardiac function assessment: ** Prior treatment with anthracyclines ** Prior treatment with trastuzumab ** Prior central thoracic radiation therapy (RT), including RT to the heart ** History of myocardial infarction within 6 to 12 months (Patients with history of myocardial infarction within 6 months are excluded from the study) ** Prior history of impaired cardiac function
  • History of stroke or transient ischemic attack within six months
  • Clinical significant peripheral vascular disease or vascular disease (aortic aneurysm or aortic dissection)
  • Evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted
  • Evidence suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated * No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)
  • Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies as they may interfere with the effectiveness of the study treatments
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation with controlled ventricular rate), or psychiatric illness/social situations that would limit compliance with study requirements
  • Known human immunodeficiency virus (HIV)-positive individuals are ineligible because of the potential for pharmacokinetic interactions with cediranib or olaparib; in addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy
  • Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible * Strong inhibitors and inducers of UGT/PgP should be used with caution
  • Pregnant women are excluded from this study because cediranib and olaparib are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with cediranib and olaparib, breastfeeding should be discontinued if the mother is treated with cediranib or olaparib; these potential risks may also apply to other agents used in this study

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu

Alaska

Anchorage
Alaska Women's Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org

Arkansas

Little Rock
University of Arkansas for Medical Sciences
Status: Active
Contact: Site Public Contact
Phone: 501-686-8274

California

Carmichael
Mercy San Juan Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 916-556-3301
Email: OncologyResearch@DignityHealth.org
Greenbrae
Marin Cancer Care Inc
Status: Active
Contact: Site Public Contact
Phone: 415-925-5000
Email: info@marinspecialtycare.com
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 858-822-5354
Email: cancercto@ucsd.edu
Mountain View
Palo Alto Medical Foundation-Camino Division
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Palo Alto Medical Foundation-Gynecologic Oncology
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Oakland
Kaiser Permanente-Oakland
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Palo Alto
Palo Alto Medical Foundation Health Care
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Roseville
Sutter Roseville Medical Center
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Sacramento
Kaiser Permanente - Sacramento
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente Downtown Commons
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: kpoct@kp.org
Mercy Cancer Center - Sacramento
Status: Active
Contact: Site Public Contact
Phone: 916-556-3301
Email: OncologyResearch@DignityHealth.org
Sutter Medical Center Sacramento
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
San Francisco
California Pacific Medical Center-Pacific Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Kaiser Permanente-San Francisco
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
UCSF Medical Center-Mission Bay
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-827-3222
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Cruz
Palo Alto Medical Foundation-Santa Cruz
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Santa Rosa
Sutter Pacific Medical Foundation
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Vallejo
Kaiser Permanente-Vallejo
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Walnut Creek
Kaiser Permanente-Walnut Creek
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Woodland
Woodland Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 916-556-3301
Email: OncologyResearch@DignityHealth.org

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Penrose-Saint Francis Healthcare
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
UCHealth Memorial Hospital Central
Status: Active
Contact: Site Public Contact
Phone: 719-365-2406
Denver
Kaiser Permanente-Franklin
Status: Active
Contact: Site Public Contact
Phone: 303-764-5056
Email: josh.b.gordon@nsmtp.kp.org
Rocky Mountain Cancer Centers-Rose
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Fort Collins
Poudre Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 970-297-6150
Lafayette
Kaiser Permanente-Rock Creek
Status: Active
Contact: Site Public Contact
Phone: 303-764-5056
Email: josh.b.gordon@nsmtp.kp.org
Lone Tree
Kaiser Permanente-Lone Tree
Status: Active
Contact: Site Public Contact
Phone: 303-764-5056
Email: josh.b.gordon@nsmtp.kp.org

Connecticut

Hartford
Hartford Hospital
Status: Active
Contact: Site Public Contact
Phone: 860-545-5363
Middletown
Middlesex Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 860-358-2058
Email: beth_slifer@midhosp.org
New Britain
The Hospital of Central Connecticut
Status: Active
Contact: Site Public Contact
Phone: 860-224-5660

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Medical Oncology Hematology Consultants PA
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

District of Columbia

Washington
Sibley Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 202-243-2373
Email: jquiver1@jhmi.edu

Florida

Miami Beach
Mount Sinai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 305-674-2625
Email: yenrique@msmc.com
Orlando
UF Cancer Center at Orlando Health
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com
Sarasota
Sarasota Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 941-917-2225

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: Active
Contact: Site Public Contact
Phone: 888-946-7447
Northside Hospital
Status: Active
Contact: Site Public Contact
Phone: 404-303-3355
Email: ClinicalTrials@northside.com
Piedmont Hospital
Status: Active
Contact: Site Public Contact
Phone: 404-425-7943
Email: ORS@piedmont.org
Augusta
Augusta University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 706-721-2388
Email: ga_cares@augusta.edu
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org
Memorial Health University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 912-350-7887
Email: clayter1@memorialhealth.com

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: Active
Contact: Site Public Contact
Phone: 808-983-6090
Queen's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 808-545-8548

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-2774
Email: eslinget@slhs.org
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org

Illinois

Aurora
Rush - Copley Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com
Bloomington
Illinois CancerCare-Bloomington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Carthage
Illinois CancerCare-Carthage
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Centralia
Centralia Oncology Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Chicago
John H Stroger Jr Hospital of Cook County
Status: Active
Contact: Site Public Contact
Phone: 312-864-5204
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Presence Saint Joseph Hospital-Chicago
Status: Active
Contact: Site Public Contact
Phone: 773-665-3109
Rush University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Decatur Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Eureka
Illinois CancerCare-Eureka
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: Active
Contact: Site Public Contact
Phone: 847-570-2109
Galesburg
Illinois CancerCare-Galesburg
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Geneva
Northwestern Medicine Cancer Center Delnor
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org
Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: Active
Contact: Site Public Contact
Phone: 847-570-2109
Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 847-570-2109
Hinsdale
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Status: Active
Contact: Site Public Contact
Phone: 630-856-6757
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Princeton
Illinois CancerCare-Princeton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-788-3528
Springfield Clinic
Status: Active
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: Active
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org
Zion
Midwestern Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org

Indiana

Fort Wayne
Parkview Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-784-4673
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
Saint Vincent Hospital and Health Care Center
Status: Active
Contact: Site Public Contact
Phone: 317-338-2194
Email: research@stvincent.org
Richmond
Reid Health
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
South Bend
Memorial Hospital of South Bend
Status: Active
Contact: Site Public Contact
Phone: 800-284-7370

Iowa

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Cancer Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Des Moines
Iowa Methodist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Medical Center - Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225
Sioux City
Siouxland Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 712-252-9326
Email: HoopingarnerT@jencc.com
West Des Moines
Mercy Medical Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Kansas

Wichita
Ascension Via Christi Hospitals Wichita
Status: Active
Contact: Site Public Contact
Phone: 800-362-0070
Email: Keisha.humphries@ascension.org
Associates In Womens Health
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org

Kentucky

Edgewood
Saint Elizabeth Medical Center South
Status: Active
Contact: Site Public Contact
Phone: 859-301-5473
Email: darla.hehman@stelizabeth.com
Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 859-257-3379

Louisiana

Baton Rouge
Hematology / Oncology Clinic LLP
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 225-767-0822
Mary Bird Perkins Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
Woman's Hospital
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: Clinicalreserach@marybird.com
Covington
Women's Cancer Care-Covington
Status: Active
Contact: Site Public Contact
Phone: 225-215-1353
Email: clinicalresearch@marybird.com
New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org

Maine

Bangor
Eastern Maine Medical Center
Status: Active
Contact: Site Public Contact
Phone: 207-973-4274
Brewer
Lafayette Family Cancer Center-EMMC
Status: Active
Contact: Site Public Contact
Phone: 800-987-3005
Scarborough
Maine Medical Center- Scarborough Campus
Status: Active
Contact: Site Public Contact
Phone: 207-396-8090
Email: wrighd@mmc.org

Maryland

Baltimore
Greater Baltimore Medical Center
Status: Active
Contact: Site Public Contact
Phone: 443-849-3706
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu
Bethesda
National Institutes of Health Clinical Center
Status: Active
Contact: Site Public Contact
Phone: 800-411-1222
Salisbury
Peninsula Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 866-922-6237

Massachusetts

Boston
Brigham and Women's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 617-724-5200
Dana-Farber Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 877-442-3324
Worcester
University of Massachusetts Memorial Health Care
Status: Active
Contact: Site Public Contact
Phone: 508-856-6265

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Brownstown
Henry Ford Cancer Institute-Downriver
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Detroit
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Escanaba
Green Bay Oncology - Escanaba
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Farmington Hills
Weisberg Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Grand Rapids
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Lansing
Sparrow Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Pontiac
Saint Joseph Mercy Oakland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Traverse City
Munson Medical Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 218-333-5000
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Burnsville
Fairview Ridges Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Edina
Fairview-Southdale Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maple Grove
Fairview Maple Grove Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maplewood
Saint John's Hospital - Healtheast
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Minneapolis
Abbott-Northwestern Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
University of Minnesota / Masonic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 612-624-2620
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
United Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Shakopee
Saint Francis Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Mississippi

Jackson
University of Mississippi Medical Center
Status: Active
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Columbia
University of Missouri - Ellis Fischel
Status: Active
Contact: Site Public Contact
Phone: 573-882-7440
Joplin
Mercy Hospital Joplin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 417-556-3074
Email: esmeralda.carrillo@mercy.net
Saint Louis
Barnes-Jewish Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@ccadmin.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Springfield
CoxHealth South Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520

Montana

Billings
Billings Clinic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Grand Island
CHI Health Saint Francis
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Kearney
CHI Health Good Samaritan
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Omaha
Alegent Health Bergan Mercy Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Alegent Health Lakeside Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Nebraska Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144

Nevada

Las Vegas
Women's Cancer Center of Nevada
Status: Active
Contact: Site Public Contact
Phone: 702-693-6870
Email: kmcwhirter@wccenter.com

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu
Nashua
Norris Cotton Cancer Center-Nashua
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 603-577-4282
Email: Laura.A.Menken@hitchcock.org

New Jersey

Camden
Cooper Hospital University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 856-325-6757
Morristown
Morristown Medical Center
Status: Active
Contact: Site Public Contact
Phone: 973-971-5900
Neptune
Jersey Shore Medical Center
Status: Active
Contact: Site Public Contact
Phone: 732-776-4240
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Site Public Contact
Phone: 732-235-8675
Somerville
Robert Wood Johnson University Hospital Somerset
Status: Active
Contact: Site Public Contact
Phone: 908-685-2481
Summit
Overlook Hospital
Status: Active
Contact: Site Public Contact
Phone: 908-522-2043
Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 856-325-6757

New Mexico

Albuquerque
Southwest Gynecologic Oncology Associates Inc
Status: Active
Contact: Site Public Contact
Phone: 505-272-0530
Email: RDraper@nmcca.org
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org
Las Cruces
Memorial Medical Center - Las Cruces
Status: Active
Contact: Site Public Contact
Phone: 575-556-6545
Email: Kim.Hoffman@lpnt.net

New York

Albany
Women's Cancer Care Associates LLC
Status: Active
Contact: Site Public Contact
Phone: 518-458-1390
Email: jbarlin@womenscancercareassociates.com
Bronx
Montefiore Medical Center-Einstein Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Site Public Contact
Phone: 212-263-4434
Email: prmc.coordinator@nyumc.org
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Site Public Contact
Phone: 315-464-5476
White Plains
Dickstein Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 914-849-7582
Email: mcortese@wphospital.org

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Durham
Duke University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-275-3853
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 919-587-9077
Email: ecooke@cancersmoc.com
Hendersonville
Margaret R Pardee Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 828-696-4716
Email: karen.morris@unchealth.unc.edu
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 910-353-0824
Email: ecooke@cancersmoc.com
Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Status: Active
Contact: Site Public Contact
Phone: 910-715-3500
Email: jcwilliams@firsthealth.org
Raleigh
Duke Raleigh Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 919-862-5400
Wilmington
New Hanover Regional Medical Center / Zimmer Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 910-342-3000
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Roger Maris Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Ohio

Akron
Cleveland Clinic Akron General
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Centerville
Miami Valley Hospital South
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Cincinnati
Good Samaritan Hospital - Cincinnati
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
TriHealth Cancer Institute-Westside
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Cleveland
Cleveland Clinic Cancer Center / Fairview Hospital
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Cleveland Clinic Foundation
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
MetroHealth Medical Center
Status: Active
Contact: Site Public Contact
Phone: 216-778-8526
Email: dstrater@metrohealth.org
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Riverside Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
The Mark H Zangmeister Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Dayton
Grandview Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-395-8115
Findlay
Orion Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Sylvania
ProMedica Flower Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-824-1842
Toledo
The Toledo Hospital / Toledo Children's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu
Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Status: Active
Contact: Site Public Contact
Phone: 918-505-3200

Oregon

Portland
Legacy Good Samaritan Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-220-4937
Email: cancer@lhs.org
Tualatin
Legacy Meridian Park Hospital
Status: Active
Contact: Site Public Contact
Phone: 503-413-1742

Pennsylvania

Abington
Abington Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 215-481-2402
Bethlehem
Saint Luke's University Hospital-Bethlehem Campus
Status: Active
Contact: Site Public Contact
Phone: 484-503-4151
Bryn Mawr
Bryn Mawr Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Ephrata
Ephrata Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 717-721-4840
Ephrata Community Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Gettysburg
Adams Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-441-7957
Hanover
Cherry Tree Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-441-7957
Lebanon
Sechler Family Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 717-741-8303
Email: doxenberg@wellspan.org
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Email: HemonCCTrials@geisinger.edu
Paoli
Paoli Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-474-9892
Pittsburgh
West Penn Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-578-5000
Sayre
Guthrie Medical Group PC-Robert Packer Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-836-0388
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Williamsport
UPMC Susquehanna
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-598-4282
Willow Grove
Abington Memorial Hospital-Asplundh Cancer Pavilion
Status: Active
Contact: Site Public Contact
Phone: 215-481-2402
Wynnewood
Lankenau Medical Center
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
York
WellSpan Health-York Hospital
Status: Active
Contact: Site Public Contact
Phone: 877-441-7957

Rhode Island

Providence
Women and Infants Hospital
Status: Active
Contact: Site Public Contact
Phone: 401-274-1122

South Carolina

Anderson
AnMed Health Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 864-512-4651
Email: rhonda.ballew@anmedhealth.org
Greenville
Saint Francis Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org
Saint Francis Hospital
Status: Active
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org
Hilton Head Island
South Carolina Cancer Specialists PC
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org

South Dakota

Rapid City
Rapid City Regional Hospital
Status: Active
Contact: Site Public Contact
Phone: 605-716-3982
Email: research@rcrh.org
Sioux Falls
Avera Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-634-7268
Email: oncregulatory@avera.org
Sanford Cancer Center Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicTrialsSF@sanfordhealth.org
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Kingsport
Regional Cancer Center at Indian Path Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 423-578-8538
Email: Justin.reynolds@balladhealth.org
Wellmont Holston Valley Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 423-578-8538
Email: justin.reynolds@wellmont.org
Knoxville
Thompson Cancer Survival Center
Status: Active
Contact: Site Public Contact
Phone: 865-331-1812
Thompson Cancer Survival Center - West
Status: Active
Contact: Site Public Contact
Phone: 865-331-1812
Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Dallas
Parkland Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 214-590-5582
Email: canceranswerline@UTSouthwestern.edu
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Houston
Methodist Willowbrook Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
The Methodist Hospital System
Status: Active
Contact: Site Public Contact
Phone: 713-790-2700
Sugar Land
Houston Methodist Sugar Land Hospital
Status: Active
Contact: Site Public Contact
Phone: 281-242-2873

Utah

Murray
Intermountain Medical Center
Status: Active
Contact: Site Public Contact
Phone: 801-507-3950
Email: officeofresearch@imail.org
Saint George
Dixie Medical Center Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 435-688-4167
Email: officeofresearch@imail.org
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
Utah Cancer Specialists-Salt Lake City
Status: Active
Contact: Site Public Contact
Phone: 801-933-6070
Email: officeofresearch@imail.org
South Jordan
South Jordan Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 802-225-5400
Burlington
University of Vermont and State Agricultural College
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 802-656-8990
Email: rpo@uvm.edu
University of Vermont Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 434-243-6303
Email: PAS9E@virginia.edu
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 804-628-1939
Email: mwellons@vcu.edu

Washington

Bellingham
PeaceHealth Saint Joseph Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-715-4133
Email: mjohnson9@peacehealth.org
Edmonds
Swedish Cancer Institute-Edmonds
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Kennewick
Kadlec Clinic Hematology and Oncology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 509-783-4637
Email: research@kadlecmed.org
Mount Vernon
Skagit Valley Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-814-2687
Email: rcccclinicalresearch@skagitvalleyhospital.org
Skagit Valley Hospital Regional Cancer Care Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-814-2146
Email: rcccclinicalresearch@skagitvalleyhospital.org
Seattle
Fred Hutchinson Cancer Research Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-804-8824
Northwest Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 206-668-1700
Pacific Gynecology Specialists
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Seattle Cancer Care Alliance
Status: Active
Contact: Site Public Contact
Phone: 800-804-8824
Swedish Medical Center-First Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
University of Washington Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-804-8824
Women's Cancer Center of Seattle
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 206-668-6806
Vancouver
Legacy Salmon Creek Hospital
Status: Active
Contact: Site Public Contact
Phone: 503-413-2150
Wenatchee
Wenatchee Valley Hospital and Clinics
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 509-665-5800

West Virginia

Charleston
West Virginia University Charleston Division
Status: Active
Contact: Site Public Contact
Phone: 304-388-9944
Huntington
Edwards Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 304-399-6617
Morgantown
Monongalia Hospital
Status: Active
Contact: Site Public Contact
Phone: 304-598-6560

Wisconsin

Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Chippewa Falls
Marshfield Clinic-Chippewa Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Eau Claire
Marshfield Clinic Cancer Center at Sacred Heart
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Fond Du Lac
Aurora Health Center-Fond du Lac
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Germantown
Aurora Health Care Germantown Health Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Grafton
Aurora Cancer Care-Grafton
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Kenosha
Aurora Cancer Care-Kenosha South
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Ladysmith
Marshfield Clinic - Ladysmith Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Marinette
Aurora Bay Area Medical Group-Marinette
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Saint Vincent Hospital Cancer Center at Marinette
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Marshfield
Marshfield Medical Center-Marshfield
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Milwaukee
Aurora Cancer Care-Milwaukee
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Aurora Saint Luke's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Aurora Sinai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Medical College of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-805-3666
Minocqua
Marshfield Clinic-Minocqua Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Mukwonago
ProHealth D N Greenwald Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: research.institute@phci.org
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 262-928-7878
Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Racine
Aurora Cancer Care-Racine
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Rice Lake
Marshfield Medical Center-Rice Lake
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Stevens Point
Ascension Saint Michael's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Marshfield Clinic Stevens Point Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Summit
Aurora Medical Center in Summit
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Waukesha
ProHealth Waukesha Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 262-928-5539
Email: Chanda.miller@phci.org
Wausau
Marshfield Clinic-Wausau Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Weston
Marshfield Clinic - Weston Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org

Ontario

Barrie
Royal Victoria Regional Health Centre
Status: Active
Contact: Site Public Contact
Phone: 705-739-5661
Hamilton
Juravinski Cancer Centre at Hamilton Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 905-387-9495
London
London Regional Cancer Program
Status: Active
Contact: Site Public Contact
Phone: 519-685-8600
Sault Ste Marie
Algoma District Cancer Program Sault Area Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 705-759-3434
Toronto
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Status: Active
Contact: Site Public Contact
Phone: 416-480-5000
University Health Network-Princess Margaret Hospital
Status: Active
Contact: Site Public Contact
Phone: 416-946-4501
Email: clinical.trials@uhn.on.ca

Quebec

Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: Active
Contact: Site Public Contact
Phone: 514-890-8000ext12725
Email: info.cr.chum@ssss.gouv.qc.ca
CHUM - Hopital Notre-Dame
Status: Temporarily closed to accrual
Contact: Diane M. Provencher
Phone: 514-890-8000ext14788
Email: marie-josee.samson.chum@ssss.gouv.qc.ca
Jewish General Hospital
Status: Active
Contact: Site Public Contact
Phone: 514-340-8222ext8248
Quebec City
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Status: Active
Contact: Site Public Contact
Email: rechclinique@crchuq.ulaval.ca

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess the efficacy and identify (in)active arm(s) of the combination of cediranib maleate (cediranib) and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by progression-free survival (PFS) in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase II)

II. To assess the efficacy of the combination of cediranib and olaparib, and cediranib monotherapy, as measured by overall survival (OS) and PFS, as compared to physician's choice standard of care chemotherapy in women with recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)

SECONDARY OBJECTIVES:

I. To assess the efficacy of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by objective response rate (ORR: partial or complete response) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase II)

II. To assess safety endpoints, as measured by frequency and severity of adverse events by Common Terminology Criteria for Adverse Events (CTCAE). (Phase II and Phase III)

III. To assess the efficacy of the combination of cediranib and olaparib, and cediranib monotherapy, as measured by ORR as compared to physician’s choice standard of care chemotherapy in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)

OBJECTIVES WITH INTEGRATED BIOMARKERS:

I. To assess correlation of homologous recombination deficiency (HRD) status, as assessed via BROCA-HR assay with response, as measured by PFS and ORR. (Phase II)

II. To evaluate the prognostic and predictive role of circulating endothelial cells (CEC) on comparative effectiveness of targeted therapies and reference chemotherapy. (Phase II)

III. To evaluate quality of life data compliance, as measured by the 9-item Disease Related Symptoms (DRS-9) subscale of the National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT) Ovarian Symptom Index (NFOSI) for utilization and analysis in the Phase III study. (Phase II)

IV. To assess correlation of HRD status, as assessed via BROCA-HR assay with response, as measured by OS, PFS and ORR. (Phase III)

V. To evaluate the prognostic and predictive role of circulating endothelial cells (CEC) on comparative effectiveness of targeted therapies and reference chemotherapy. (Phase III)

VI. To assess the effect on disease-related symptoms (DRS) as measured by the 9-item DRS-P subscale of the NCCN-FACT Ovarian Symptom Index-18 (NFOSI-18), of single agent cediranib and cediranib/olaparib combination, compared to standard chemotherapy, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)

EXPLORATORY OBJECTIVES:

I. To assess exploratory biomarkers of potential HRD, including genomic scarring, BRCA1 methylation, BRCA1 protein expression, and mutations in NHEJ, and other genes that might modify HRD. (Phase II and Phase III)

II. To evaluate the prognostic and predictive role of angiogenic biomarkers, as assessed by the Duke plasma angiome. (Phase II and Phase III)

III. To assess the effect on secondary measures of quality of life, as assessed by the treatment side effects (TSE) and function/well-being (F/WB) subscales of the NFOSI-18, sensory neuropathy as measured by the FACT/GOG-Ntx-4, and health utility as measured by the EQ-5D, of single agent cediranib and cediranib/olaparib combination, compared to standard chemotherapy, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)

OUTLINE:

PHASE II: Patients are randomized to 1 of 4 treatment arms.

ARM I (REFERENCE REGIMEN): Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. (12/05/2016)

ARM II (CEDIRANIB MALEATE AND OLAPARIB): Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM III (CEDIRANIB): Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM IV (OLAPARIB): Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).

PHASE III: Patients are randomized to 1 of 3 treatment arms.

ARM I (REFERENCE REGIMEN): Patients undergo physician's choice standard of care chemotherapy as in Phase II Arm I. No modification of the assigned regimens, such as additional drugs (gemcitabine or bevacizumab) is allowed. (12/05/2016)

ARM II (CEDIRANIB AND OLAPARIB): Patients receive cediranib maleate PO and olaparib PO as in Phase II Arm II.

ARM III (SINGLE AGENT): Patients receive cediranib maleate PO as determined by the Phase II study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for up to 3 years.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Jung-min Lee

Trial IDs

Primary ID NRG-GY005
Secondary IDs NCI-2015-00651, s16-01681
Clinicaltrials.gov ID NCT02502266