Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentClosed18 and overNCINCI-2011-03812
CDR0000681448, GOG-0262/ACRIN 6695, GOG-0262, U10CA180868, U10CA027469, NCT01167712

Trial Description

Summary

This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. It is not yet known whether giving paclitaxel once every three weeks is more effective than giving paclitaxel once a week.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if the weekly paclitaxel regimen increases the time until first progression or death (progression-free survival [PFS]) compared to the every-3-week paclitaxel regimen in women with primary stage II, III or IV epithelial ovarian, peritoneal or fallopian tube cancer who are receiving carboplatin with or without bevacizumab.

SECONDARY OBJECTIVES:

I. To determine if the weekly paclitaxel increases the duration of overall survival compared to the every-3-week paclitaxel when combined with carboplatin with or without bevacizumab.

II. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to the incidence of severe or serious adverse events when it is combined with carboplatin with or without bevacizumab.

III. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to patients' self-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)-Trial Outcome Index (TOI), when paclitaxel is combined with carboplatin with or without bevacizumab. (As of 02/08/2012, the QOL portion of this study is complete; patients enrolled after this date will not have QOL assessments)

TERTIARY OBJECTIVES:

I. To evaluate single nucleotide polymorphisms (SNPs) associated with progression-free survival and toxicity in advanced stage epithelial ovarian, peritoneal and fallopian tube cancer using genome wide association studies (GWAS).* II. To evaluate genomic signatures in tumor tissues which are predictive for patient survival in advanced stage epithelial ovarian, peritoneal and fallopian tube cancer.* III. To evaluate the association between serum and plasma biomarkers and response to anti-angiogenesis therapy in advanced stage epithelial ovarian, peritoneal, and fallopian tube cancer.*

NOTE: *As of 02/08/2012, the translational research portion of this study is complete; patients enrolled after this date will not have TR specimens collected.

IMAGING PRIMARY OBJECTIVES:

I. To determine whether larger changes in the tumor perfusion parameters from baseline timepoint (T0) to early-therapy T2 are prognostic of higher progression-free survival (PFS) rate at 6 months (PFS-6) from enrollment in patients treated with weekly or every-3-week paclitaxel regimens, who are receiving carboplatin with or without bevacizumab.***

IMAGING SECONDARY OBJECTIVES:

I. To determine whether larger changes in tumor perfusion parameters from baseline T0 to intermediate T1 and from T1 to T2 are prognostic of higher PFS-6 in patients treated with weekly or every-3-week paclitaxel regimens, who are receiving carboplatin with or without bevacizumab.*** II. To determine whether larger changes in tumor perfusion parameters values from T0 to T1, T0 to T2, and T1 to T2 are prognostic of better overall survival in all treatment arms.*** III. To assess the association between changes in tumor perfusion parameters before and after chemotherapy initiation (T0 to T1) and subsequent best tumor response according to standard anatomic Response Evaluation Criteria in Solid Tumors (RECIST).*** IV. To assess the association between tumor perfusion parameters before chemotherapy and subsequent best tumor response according to RECIST, PFS-6, and overall survival.*** V. To test the assumption that tumor perfusion parameters are reliable, user-independent, and reproducible parameters of tumor microvascular characteristics; a subgroup of 15 patients will have repeat computed tomography (CT) perfusion studies at the intermediate T1 time point.***

NOTE: ***Patients enrolled after February 8, 2012 must participate in the ACRIN 6695 component at ACRIN-qualified institutions.

OUTLINE: Patients are randomized to 1 of 2 treatment arms (beginning on 04-30-2012, the trial is no longer randomized and the chemotherapy regimen is selected and declared prior to enrolling in the study).

ARM I (adjuvant chemotherapy suboptimally debulked): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

ARM II (neoadjuvant chemotherapy with interval cytoreductive surgery): Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.

Patients in both arms may receive optional** bevacizumab IV over 30-90 minutes on day 1 beginning in course 2. Courses of bevacizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients in Arm II receive bevacizumab during courses 2, 5, and 6 only.

NOTE: **Before enrolling onto this study, each patient chooses whether the study treatment will include concurrent and maintenance bevacizumab.

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

Eligibility Criteria

Inclusion Criteria:

  • Primary Surgery and Neoadjuvant Chemotherapy with Interval Cytoreductive Surgery Patients:
  • Patients must have measurable disease; at least one target lesion must have a minimum length of 1 cm in both the long and short axis (determined at the local site); for primary surgery patients, if no radiographic evidence of measurable disease is obtained prior to registration this can be based on surgical findings; imaging then would need to be completed in the 14 days between Gynecology Oncology Group (GOG) registration and chemotherapy initiation
  • Primary Surgery Patients:
  • Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer, stage II -IV suboptimally debulked (any residual disease > 1 cm); International Federation of Gynecology and Obstetrics (FIGO) stage is assessed following the completion of initial abdominal surgery, appropriate imaging studies and with appropriate tissue available for histologic evaluation; the minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual
  • Neoadjuvant Chemotherapy (NAC) with Interval Cytoreductive Surgery (ICS) Patients:
  • For patients undergoing NAC-ICS, a core tissue (not fine needle aspiration) biopsy is required; the tissue must be consistent with a müllerian origin; patients will require documentation of at least stage II or extraovarian sites of disease acquired via imaging or surgery (without attempt at cytoreduction)
  • Patients with the following histologic epithelial cell types are eligible: serous, endometrioid, clear cell, mucinous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; patients may have co-existing fallopian tube carcinoma in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or fallopian tube; of note, patients with clear cell and mucinous tumors will be eligible unless there is a higher priority protocol
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
  • Platelets greater than or equal to 100,000/mcl
  • Creatinine =< 1.5 x institutional upper limit normal (ULN)
  • Bilirubin less than or equal to 1.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Neuropathy (sensory or motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • Patients must have a GOG performance status of 0, 1, or 2
  • Patients must be entered within 12 weeks of diagnostic/staging surgery
  • Patients who have met the pre-entry requirements
  • An approved informed consent and authorization permitting release of personal health information and must be signed by the patient or guardian
  • Only applies for patients who elect to receive bevacizumab:
  • Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but not high-dose progestins for management of anorexia while on protocol-directed therapy or prior to disease progression due to thrombophlebitis risk
  • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a partial prothrombin time (PTT) < 1.2 times the upper limit of normal; (heparin, lovenox or alternative anticoagulants are acceptable)
  • All patients enrolled into GOG-0262 at sites where ACRIN 6695 is open will be enrolled in the advanced imaging protocol; patients receiving adjuvant or neoadjuvant chemotherapy are eligible for ACRIN 6695; the following sentence does not apply to those patients entered after 02/08/2012: if a patient declines to participate in the perfusion imaging portion of the protocol, a clinical rationale for declination of imaging form will be completed as part of the data submission for ACRIN 6695
  • ACRIN 6695 Eligible Patients:
  • Confirmation of ACRIN 6695 eligibility after the baseline T0 perfusion computed tomography (CT) will be assessed by the American College of Radiology (ACR) Imaging Core Lab: At least one target lesion must have a minimum length of 1 cm in both the long and short axis (as determined by the local site), at least half of the target lesion must have attenuation greater than or equal to 10 Hounsfield Units (HU) on the unenhanced CT, and at least half of the lesion must have maximum enhancement greater than or equal to 5 HU in the perfusion CT scan (as determined by the ACR Imaging Core Lab)

Exclusion Criteria:

  • Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage I-A or I-B low grade epithelial ovarian or fallopian tube cancers) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
  • Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
  • With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy
  • Patients with acute hepatitis or active infection that requires parenteral antibiotics
  • Patients with clinically significant cardiovascular disease; this includes:
  • Myocardial infarction or unstable angina < 6 months prior to registration
  • New York Heart Association (NYHA) grade II or greater congestive heart failure
  • Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
  • Patients who are pregnant or nursing; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy
  • Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab
  • 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 should feel free to consult the Statistical and Data Center (SDC) randomization desk for uncertainty in this regard
  • Patients with known allergy to cremophor or polysorbate 80
  • Only applies to patients who elect to receive bevacizumab:
  • Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
  • Patients with CTCAE grade 2 or greater peripheral vascular disease (at least brief [< 24 hours] episodes of ischemia managed non-surgically and without permanent deficit)
  • Patients with a history of CVA within six months
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24-hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24-hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR < 1.0 to allow participation in the study
  • Patients with or with anticipation of invasive procedures as defined below:
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy (cycle 2)
  • Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression such as colostomy or enterostomy reversal, secondary cytoreductive surgery, or second look surgery; please consult with the SDC Randomization Desk prior to patient entry for any questions related to the classification of surgical procedures
  • Any tissue biopsy, such as a core biopsy, within 7 days prior to the first date of bevacizumab therapy (cycle 2)
  • Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition
  • Patients with metastasis tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patients at high risk of lethal hemorrhage during treatment with bevacizumab (ie. hemoptysis, liver rupture)
  • ACRIN 6695 Ineligible Patients:
  • Patients with contraindication to iodinated contrast for perfusion CT imaging
  • Patients who receive Metformin within 48 hours before perfusion CT imaging

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    John Chan, Principal Investigator

    Trial Sites

    U.S.A.

    Alabama
    Mobile

    University of South Alabama Mitchell Cancer Institute

    Rodney P Rocconi
    Ph: 251-445-9870
    Email: pfrancisco@usouthal.edu

    Arkansas
    Hot Springs

    St. Joseph's Mercy Cancer Center

    Manjusha Kota
    Ph: 888-823-5923
    Email: ctsucontact@westat.com

    California
    Castro Valley

    East Bay Radiation Oncology Center

    James H. Feusner
    Ph: 510-450-7600

    Valley Medical Oncology Consultants - Castro Valley

    James H. Feusner
    Ph: 510-450-7600

    Emeryville

    Bay Area Breast Surgeons, Incorporated

    James H. Feusner
    Ph: 510-450-7600

    Fremont

    Valley Medical Oncology

    James H. Feusner
    Ph: 510-450-7600

    La Jolla

    Rebecca and John Moores UCSD Cancer Center

    Michael T. McHale
    Ph: 858-822-5354
    Email: cancercto@ucsd.edu

    Los Angeles

    Kaiser Permanente Medical Center - Los Angeles

    Scott E. Lentz
    Ph: 626-564-3455

    Martinez

    Contra Costa Regional Medical Center

    James H. Feusner
    Ph: 510-450-7600

    Mountain View

    El Camino Hospital Cancer Center

    James H. Feusner
    Ph: 510-450-7600

    Oakland

    Alta Bates Summit Medical Center - Summit Campus

    James H. Feusner
    Ph: 510-450-7600

    CCOP - Bay Area Tumor Institute

    James H. Feusner
    Ph: 510-450-7600

    Highland General Hospital

    James H. Feusner
    Ph: 510-450-7600

    Larry G Strieff MD Medical Corporation

    James H. Feusner
    Ph: 510-450-7600

    Tom K Lee, Incorporated

    James H. Feusner
    Ph: 510-450-7600

    San Pablo

    Doctors Medical Center - San Pablo Campus

    James H. Feusner
    Ph: 510-450-7600

    Santa Clara

    Kaiser Permanente Medical Center - Santa Clara Homestead Campus

    Louis Fehrenbacher
    Ph: 626-564-3455

    Colorado
    Fort Collins

    Front Range Cancer Specialists

    Robert F Marschke
    Ph: 970-482-3328

    Poudre Valley Hospital

    Paolo Romero
    Ph: 970-495-8226

    Delaware
    Lewes

    Tunnell Cancer Center at Beebe Medical Center

    Mark E Borowsky
    Ph: 302-733-6227

    Newark

    Helen F. Graham Cancer Center at Christiana Hospital

    Mark E Borowsky
    Ph: 302-733-6227

    Florida
    Clearwater

    Morton Plant Hospital

    Hector A. Arango
    Ph: 727-461-8519

    Fort Myers

    Florida Gynecologic Oncology - Fort Myers

    Edward C. Grendys
    Ph: 800-874-7502

    Lakeland

    Center for Cancer Care and Research at Watson Clinic, LLP

    Richard J Cardosi
    Ph: 863-680-7780

    Orlando

    Florida Hospital Cancer Institute at Florida Hospital Orlando

    James E Kendrick
    Ph: 407-303-5623

    Illinois
    Decatur

    Decatur Memorial Hospital Cancer Care Institute

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Maywood

    Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Donna Marie Smith
    Ph: 708-226-4357

    Moline

    Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

    Costas L. Constantinou
    Ph: 319-363-2690

    Springfield

    Regional Cancer Center at Memorial Medical Center

    James L. Wade
    Ph: 217-876-4740
    Email: kcheek@dmhhs.org

    Warrenville

    Central Dupage Cancer Center

    Laura E Horvath
    Ph: 773-834-7424

    Indiana
    Beech Grove

    St. Francis Hospital and Health Centers - Beech Grove Campus

    Howard M. Gross
    Ph: 317-783-8918

    Munster

    Community Hospital

    Mohamad Kassar
    Ph: 219-836-3349

    Richmond

    Reid Hospital & Health Care Services

    Howard M. Gross
    Ph: 317-783-8918

    Iowa
    Mason City

    Mercy Cancer Center at Mercy Medical Center - North Iowa

    Arvind Y Vemula
    Ph: 800-433-3883

    Kansas
    Overland Park

    Menorah Medical Center

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    Saint Luke's Hospital - South

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    Prairie Village

    CCOP - Kansas City

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    Louisiana
    New Orleans

    Medical Center of Louisiana - New Orleans

    Robert W Veith
    Ph: 504-568-3410
    Email: aconne1@lsuhsc.edu

    Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans

    Robert W Veith
    Ph: 504-568-3410
    Email: aconne1@lsuhsc.edu

    Tulane Cancer Center at Tulane University Hospital and Clinic

    William R. Robinson
    Ph: 504-988-6121

    Shreveport

    Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Robin A Lacour
    Ph: 318-813-1412

    Highland Clinic

    Manish Dhawan
    Ph: 318-798-4630

    Maryland
    Elkton MD

    Union Hospital of Cecil County

    Mark E Borowsky
    Ph: 302-733-6227

    Michigan
    Flint

    Genesys Hurley Cancer Institute

    Philip J. Stella
    Ph: 734-712-3456

    Minnesota
    Duluth

    St. Luke's Hospital Cancer Care Center

    Tanya L. Repka
    Ph: 888-823-5923
    Email: ctsucontact@westat.com

    Fergus Falls

    Lake Region Healthcare Corporation-Cancer Care

    Preston D. Steen
    Ph: 701-234-6161

    Mississippi
    Jackson

    St. Dominic Cancer Center

    Donald P Seago
    Ph: 601-200-3300

    Missouri
    Kansas City

    Heartland Hematology Oncology Associates, Incorporated

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    North Kansas City Hospital

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    Research Medical Center

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    Saint Luke's Cancer Institute at Saint Luke's Hospital

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    Saint Luke's Hospital

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    Lee's Summit

    Saint Luke's East - Lee's Summit

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    Liberty

    Parvin Radiation Oncology

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    Saint Joseph

    Heartland Regional Medical Center

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    Saint Joseph Oncology, Incorporated

    Rakesh Gaur
    Ph: 913-948-5588
    Email: amy.krushelniski@hcahealthcare.com

    Nebraska
    Kearney

    Good Samaritan Cancer Center at Good Samaritan Hospital

    Cynthia M. Lewis
    Ph: 308-865-7963

    New Jersey
    Phillipsburg

    Women’s Institute for Gynecologic Cancer and Special Pelvic Surgery

    David Foster Silver
    Ph: 718-765-2500

    New York
    New York

    New York University Medical Center

    Stephanie V. Blank
    Ph: 212-263-4434
    Email: prmc.coordinator@nyumc.org

    North Carolina
    Rutherfordton

    Rutherford Hospital

    David Griffin
    Ph: 864-512-1000

    North Dakota
    Bismarck

    Bismarck Cancer Center

    Edward J. Wos
    Ph: 701-323-5760
    Email: tfischer@mohs.org

    Ohio
    Akron

    McDowell Cancer Center at Akron General Medical Center

    Eric L. Jenison
    Ph: 330-344-6041

    Dayton

    CCOP - Dayton

    Howard M. Gross
    Ph: 317-783-8918

    David L. Rike Cancer Center at Miami Valley Hospital

    John W Moroney
    Ph: 937-208-2079

    Good Samaritan Hospital

    Howard M. Gross
    Ph: 317-783-8918

    Grandview Hospital

    Howard M. Gross
    Ph: 317-783-8918

    Samaritan North Cancer Care Center

    Howard M. Gross
    Ph: 317-783-8918

    Findlay

    Blanchard Valley Regional Cancer Center

    Howard M. Gross
    Ph: 317-783-8918

    Franklin

    Atrium Medical Center

    Howard M. Gross
    Ph: 317-783-8918

    Greenville

    Wayne Hospital

    Howard M. Gross
    Ph: 317-783-8918

    Lima

    St. Rita's Medical Center

    Henry Gerad
    Ph: 419-226-9617

    Troy

    UVMC Cancer Care Center at Upper Valley Medical Center

    Howard M. Gross
    Ph: 317-783-8918

    Xenia

    Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Howard M. Gross
    Ph: 317-783-8918

    Oregon
    Portland

    Knight Cancer Institute at Oregon Health and Science University

    Tanja Pejovic
    Ph: 503-494-1080
    Email: trials@ohsu.edu

    Pennsylvania
    Allentown

    Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Richard M. Boulay
    Ph: 610-402-2273

    South Carolina
    Anderson

    AnMed Cancer Center

    David Griffin
    Ph: 864-512-1000

    Virginia
    Danville

    Danville Regional Medical Center

    Timothy W. Brotherton
    Ph: 434-793-0044

    Washington
    Yakima

    North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Sean F. Cleary
    Ph: 877-902-3324

    Wisconsin
    Antigo

    Langlade Memorial Hospital

    Christopher G Peterson
    Ph: 877-405-6866

    Appleton

    Fox Valley Hematology and Oncology - East Grant Street

    Avi Bar-Lev
    Ph: 920-749-1171

    Chippewa Falls

    Marshfield Clinic - Chippewa Center

    Anthony C. Evans
    Ph: 715-389-4457

    Eau Claire

    Marshfield Clinic Cancer Care at Regional Cancer Center

    Anthony C. Evans
    Ph: 715-389-4457

    Green Bay

    Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Dhimant R. Patel
    Ph: 800-252-2990

    Marshfield

    Marshfield Clinic - Marshfield Center

    Anthony C. Evans
    Ph: 715-389-4457

    Milwaukee

    Aurora Sinai Medical Center

    Ali Mahdavi
    Ph: 414-649-5717
    Email: ucstudy@uci.edu

    Minocqua

    Marshfield Clinic - Lakeland Center

    Anthony C. Evans
    Ph: 715-389-4457

    Oshkosh

    Vince Lombardi Cancer Clinic - Oshkosh

    Zahid N Dar
    Ph: 800-252-2990

    Rhinelander

    Ministry Medical Group at Saint Mary's Hospital

    Anthony C. Evans
    Ph: 715-389-4457

    Rice Lake

    Marshfield Clinic - Indianhead Center

    Anthony C. Evans
    Ph: 715-389-4457

    Stevens Point

    Marshfield Clinic at Saint Michael's Hospital

    Anthony C. Evans
    Ph: 715-389-4457

    Summit

    Aurora Medical Center

    Ali Mahdavi
    Ph: 414-649-5717
    Email: ucstudy@uci.edu

    Wausau

    University of Wisconcin Cancer Center at Aspirus Wausau Hospital

    Christopher G Peterson
    Ph: 877-405-6866

    Weston

    Diagnostic and Treatment Center

    Anthony C. Evans
    Ph: 715-389-4457

    Marshfield Clinic - Weston Center

    Anthony C. Evans
    Ph: 715-389-4457

    Wisconsin Rapids

    Marshfield Clinic - Wisconsin Rapids Center

    Anthony C. Evans
    Ph: 715-389-4457

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01167712
    ClinicalTrials.gov processed this data on April 09, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.