Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients with Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors

Status: Active

Description

This randomized phase II trial studies paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with sex cord-ovarian stromal tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has returned (recurrent). 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.

Eligibility Criteria

Inclusion Criteria

  • Patients with histologically confirmed ovarian stromal tumor [granulosa cell tumor, ganulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules]
  • Patients must have newly diagnosed, stage IIA – IV disease and must be entered within eight weeks from surgery; they may have either measurable residual disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, or they may have no measurable residual disease; OR, they must have biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy
  • Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
  • Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control
  • Patients in the measureable disease cohort must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • Platelet greater than or equal to 100,000/mcl
  • Creatinine no greater than the institutional upper limits of normal
  • Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3.0 x ULN (CTCAE grade 1)
  • Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)
  • Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
  • No signs of clinically significant hearing loss
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must have pulmonary function sufficient to receive bleomycin, with normal lung expansion, absence of crackles on auscultation, and normal carbon monoxide diffusion (DLCO), defined as greater than 80% predicted
  • Patients with a history of hypersensitivity reactions to prior chemotherapy administered for previous cancer diagnoses are eligible to participate in the study, unless the hypersensitivity reaction consisted of anaphylaxis not amenable to desensitization
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy * Patients must be entered within 8 weeks after surgery performed for either 1) initial diagnosis, staging, and/or cytoreduction, or 2) (if done) management of recurrent disease in a chemonaive patient * Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted

Exclusion Criteria

  • Patients who have received any prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors (SCSTs)
  • Patients with apparent stage I disease who have not undergone a staging procedure
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years
  • Woman who are pregnant or breastfeeding
  • Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator can consult the study chair or study co-chairs for uncertainty in this regard

Locations & Contacts

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Women's Cancer Care
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Anchorage Oncology Centre
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
Status: Temporarily closed to accrual
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

California

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 818-847-4793
Email: Najee.Boucher@providence.org
Sylmar
Olive View-University of California Los Angeles Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 818-364-1555

Connecticut

Hartford
Hartford Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 860-545-5363
New Britain
The Hospital of Central Connecticut
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 860-224-5660

District of Columbia

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

Georgia

Atlanta
Northside Hospital
Status: Active
Contact: Site Public Contact
Phone: 404-303-3355
Email: ClinicalTrials@northside.com
Augusta
Augusta University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 706-721-2388
Email: ga_cares@augusta.edu
Cumming
Northside Hospital-Forsyth
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 404-303-3355
Email: clinicaltrials@northside.com
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Memorial Health University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 912-350-7887
Email: clayter1@memorialhealth.com

Idaho

Coeur D'Alene
Kootenai Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Post Falls
Kootenai Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Cancer Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Illinois

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
Carbondale
Memorial Hospital of Carbondale
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 618-457-5200
Email: clinical.research@sih.net
Carterville
SIH Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 618-985-3333
Email: clinical.research@sih.net
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
University of Chicago Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: kcheek@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: Temporarily closed to accrual
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
Galesburg
Illinois CancerCare-Galesburg
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Western Illinois Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-344-2831
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
Mount Vernon
Good Samaritan Regional Health Center
Status: Active
Contact: Site Public Contact
Phone: 618-242-4600
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Radiation Oncology of Northern Illinois
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
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
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
Methodist Medical Center of Illinois
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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
Valley Radiation Oncology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 815-664-4141
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
Southern Illinois University School of Medicine
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Southwest Illinois Health Services LLP
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 618-236-1000
Email: lynns@thecancercenter.com

Indiana

Indianapolis
Saint Vincent Hospital and Health Care Center
Status: Active
Contact: Site Public Contact
Phone: 317-338-2194
Email: research@stvincent.org

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 859-257-3379

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu
MedStar Franklin Square Medical Center / Weinberg Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 443-777-7364
Sinai Hospital of Baltimore
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 410-601-6120
Email: pridgely@lifebridgehealth.org

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Escanaba
Green Bay Oncology - Escanaba
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Iron Mountain
Green Bay Oncology - Iron Mountain
Status: Temporarily closed to accrual
Contact: Jonathan Edward Tammela
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org

Missouri

Bolivar
Central Care Cancer Center - Bolivar
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Bonne Terre
Parkland Health Center-Bonne Terre
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569
Branson
Cox Cancer Center Branson
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Cape Girardeau
Saint Francis Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-651-5550
Jefferson City
Capital Region Southwest Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-632-4814
Email: swooden@mail.crmc.org
Joplin
Freeman Health System
Status: Active
Contact: Site Public Contact
Phone: 417-347-4030
Email: LJCrockett@freemanhealth.com
Mercy Hospital Joplin
Status: Active
Contact: Site Public Contact
Phone: 417-556-3074
Email: esmeralda.carrillo@mercy.net
Rolla
Delbert Day Cancer Institute at PCRMC
Status: Active
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Mercy Clinic-Rolla-Cancer and Hematology
Status: Active
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-6770
Missouri Baptist Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
Status: Active
Contact: Site Public Contact
Phone: 314-353-1870
Washington University School of Medicine
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569

Montana

Anaconda
Community Hospital of Anaconda
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Saint Vincent Healthcare
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Bozeman
Bozeman Deaconess Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.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
Great Falls Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Helena
Saint Peter's Community Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Kalispell
Kalispell Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Saint Patrick Hospital - Community Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-327-3118
Email: amy.hanneman@providence.org

Nebraska

Omaha
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: 412-339-5294
Email: Roster@nrgoncology.org

New Mexico

Albuquerque
Southwest Gynecologic Oncology Associates Inc
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 505-272-0530
Email: RDraper@nmcca.org
University of New Mexico Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org

New York

Stony Brook
Stony Brook University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-862-2215

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Concord
Atrium Health Cabarrus / LCI-Concord
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 704-403-1520
Durham
Duke University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-275-3853
Winston-Salem
Wake Forest University Health Sciences
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-713-6771

Ohio

Belpre
Strecker Cancer Center-Belpre
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Chillicothe
Adena Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 877-779-7585
Email: sheree@columbusccop.org
Cleveland
Case Western Reserve University
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
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: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 216-778-8526
Email: dstrater@metrohealth.org
Columbus
Columbus Oncology and Hematology Associates Inc
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Doctors Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-3275
Email: sheree@columbusccop.org
Grant Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
Mount Carmel East Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mount Carmel Health Center West
Status: Active
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
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
Delaware
Delaware Health Center-Grady Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 740-615-0227
Email: sheree@columbusccop.org
Delaware Radiation Oncology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Grady Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-615-2403
Email: sheree@columbusccop.org
Gahanna
Central Ohio Breast and Endocrine Surgery
Status: Active
Contact: Site Public Contact
Phone: 614-488-2745
Email: sheree@columbusccop.org
Lancaster
Fairfield Medical Center
Status: Active
Contact: Site Public Contact
Phone: 740-687-8863
Email: sheree@columbusccop.org
Lancaster Radiation Oncology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Mansfield
OhioHealth Mansfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-526-8018
Email: sheree@columbusccop.org
Marietta
Marietta Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Marion
OhioHealth Marion General Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Mount Vernon
Knox Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-393-9000
Email: sheree@columbusccop.org
Newark
Licking Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 740-348-4000
Email: sheree@columbusccop.org
Newark Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Portsmouth
Southern Ohio Medical Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Springfield
Springfield Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Westerville
Saint Ann's Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Zanesville
Genesis Healthcare System Cancer Care Center
Status: Active
Contact: Site Public Contact
Phone: 740-454-5232
Email: sheree@columbusccop.org

Oklahoma

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

Oregon

Clackamas
Clackamas Radiation Oncology Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Oncology and Hematology Care Southeast
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Newberg
Providence Newberg Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Oregon City
Providence Willamette Falls Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Portland
Providence Portland Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Pennsylvania

Abington
Abington Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 215-481-2402
Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Status: Active
Contact: Site Public Contact
Phone: 570-459-2901
Email: HemonCCTrials@geisinger.edu
Jefferson Hills
Jefferson Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-359-3043
Email: ddefazio@wpahs.org
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Email: HemonCCTrials@geisinger.edu
Lewistown
Lewistown Hospital
Status: Active
Contact: Site Public Contact
Phone: 717-242-7703
Email: HemonCCTrials@geisinger.edu
Monroeville
Forbes Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-858-7746
Philadelphia
Fox Chase Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 215-728-4790
Temple University Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 215-728-2983
Pittsburgh
Allegheny General Hospital
Status: Active
Contact: Site Public Contact
Phone: 877-284-2000
West Penn Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-578-5000
Pottsville
Geisinger Cancer Services-Pottsville
Status: Active
Contact: Site Public Contact
Phone: 800-275-6401
Email: HemonCCTrials@geisinger.edu
Scranton
Community Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-703-4768
Email: HemonCCTrials@geisinger.edu
Selinsgrove
Geisinger Medical Oncology-Selinsgrove
Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Email: HemonCCTrials@geisinger.edu
State College
Geisinger Medical Group
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Wexford
Wexford Health and Wellness Pavilion
Status: Active
Contact: Site Public Contact
Phone: 412-359-3043
Email: ddefazio@wpahs.org
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu

Rhode Island

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

South Dakota

Sioux Falls
Avera Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 888-634-7268
Email: oncregulatory@avera.org

Texas

Dallas
Parkland Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 214-590-5582
Email: canceranswerline@UTSouthwestern.edu
UT Southwestern / Simmons Cancer Center-Dallas
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Houston
M D Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-312-3961

Washington

Longview
PeaceHealth Saint John Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-514-2016
Email: kmakin-bond@peacehealth.org
Vancouver
PeaceHealth Southwest Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-514-3940
Email: kmakin-bond@peacehealth.org

Wisconsin

Green Bay
Green Bay Oncology at Saint Vincent Hospital
Status: Temporarily closed to accrual
Contact: Jonathan Edward Tammela
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Green Bay Oncology Limited at Saint Mary's Hospital
Status: Temporarily closed to accrual
Contact: Jonathan Edward Tammela
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Manitowoc
Holy Family Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 920-320-2749
Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Sturgeon Bay
Green Bay Oncology - Sturgeon Bay
Status: Temporarily closed to accrual
Contact: Jonathan Edward Tammela
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org

Wyoming

Cody
Billings Clinic-Cody
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Sheridan
Welch Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin [BEP] as a reference) for newly diagnosed advanced or recurrent chemonaive ovarian sex cord-stromal tumors.

SECONDARY OBJECTIVES:

I. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.

II. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.

III. To evaluate response rate in the subset of patients with measurable disease.

TERTIARY OBJECTIVES:

I. To collect fixed and/or frozen tumor tissue for future translational research studies.

II. To explore the utility of inhibin A and inhibin B as prognostic and predictive biomarkers for ovarian sex cord-stromal tumors and to examine changes in these markers with treatment.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bleomycin sulfate IV on day 1 and etoposide phosphate* IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who have received prior radiotherapy receive etoposide phosphate on days 1-4.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Jubilee Brown

Trial IDs

Primary ID GOG-0264
Secondary IDs NCI-2011-02000, CDR0000662814
Clinicaltrials.gov ID NCT01042522