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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01042522
Recruitment Status : Recruiting
First Posted : January 5, 2010
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Granulosa Cell Tumor Ovarian Gynandroblastoma Ovarian Sertoli-Leydig Cell Tumor Ovarian Sex Cord Tumor With Annular Tubules Ovarian Sex Cord-Stromal Tumor Ovarian Sex Cord-Stromal Tumor of Mixed or Unclassified Cell Types Ovarian Steroid Cell Tumor Biological: Bleomycin Sulfate Drug: Carboplatin Drug: Cisplatin Drug: Etoposide Phosphate Other: Laboratory Biomarker Analysis Drug: Paclitaxel Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary
Actual Study Start Date : February 8, 2010
Estimated Primary Completion Date : January 2, 2024


Arm Intervention/treatment
Experimental: Arm I (paclitaxel, carboplatin)
Patients receive paclitaxel 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.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat
Experimental: Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)
Patients receive bleomycin sulfate IV on day 1 and etoposide 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.
Biological: Bleomycin Sulfate
Given IV
Other Names:
  • Blanoxan
  • BleMomycine
  • Blenoxane
  • Bleo-cell
  • Bleo-S
  • Bleocin
  • Bleolem
  • Bleomycin Sulfas
  • Bleomycin Sulphate
  • Bleomycini Sulfas
  • Blexane
  • Oil Bleo
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos
Other: Laboratory Biomarker Analysis
Correlative studies



Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 10 years ]
    The relationship of treatment to PFS will be assessed using the proportional hazards model.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: From start of treatment to time of death or the date of last contact, assessed up to 10 years ]
    The relationship of treatment to overall survival will be assessed using the proportional hazards model.

  2. Tumor response rate [ Time Frame: Up to 10 years ]
    The relationship of treatment to tumor response rate will be assessed using logistic regression models adjusted for age and stratification factor (measurable disease status).


Other Outcome Measures:
  1. Change in inhibin A and inhibin B levels [ Time Frame: Baseline to up to 2 years ]
    Pre-treatment levels of inhibin A and inhibin B will be examined in relation to OS and PFS in Cox proportional hazards models. Changes from baseline in inhibin levels will be compared between treatment groups using mixed effects models accounting for the longitudinal nature of the data. The repeated measures of inhibin will also be explored versus overall survival and PFS using time-dependent covariates in Cox proportional hazards models.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042522


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Locations
United States, Alaska
Alaska Breast Care and Surgery LLC Suspended
Anchorage, Alaska, United States, 99508
Alaska Women's Cancer Care Suspended
Anchorage, Alaska, United States, 99508
Anchorage Oncology Centre Suspended
Anchorage, Alaska, United States, 99508
Katmai Oncology Group Suspended
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center Suspended
Anchorage, Alaska, United States, 99508
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Suspended
Burbank, California, United States, 91505
Olive View-University of California Los Angeles Medical Center Suspended
Sylmar, California, United States, 91342
United States, Connecticut
Hartford Hospital Suspended
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut Suspended
New Britain, Connecticut, United States, 06050
United States, District of Columbia
Sibley Memorial Hospital Suspended
Washington, District of Columbia, United States, 20016
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Guilherme Henrique C. Cantuaria    404-303-3355      
Principal Investigator: Guilherme Henrique C. Cantuaria         
Augusta University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Sharad A. Ghamande    706-721-1663    cancer@augusta.edu   
Principal Investigator: Sharad A. Ghamande         
Northside Hospital-Forsyth Recruiting
Cumming, Georgia, United States, 30041
Contact: Guilherme Henrique C. Cantuaria    404-303-3355      
Principal Investigator: Guilherme Henrique C. Cantuaria         
Central Georgia Gynecologic Oncology Active, not recruiting
Macon, Georgia, United States, 31201
Memorial University Medical Center Suspended
Savannah, Georgia, United States, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: William E. Richards    513-558-4553    uchealthnews@uc.edu   
Principal Investigator: William E. Richards         
United States, Idaho
Kootenai Medical Center Recruiting
Coeur d'Alene, Idaho, United States, 83814
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Kootenai Cancer Center Recruiting
Post Falls, Idaho, United States, 83854
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Kootenai Cancer Clinic Recruiting
Sandpoint, Idaho, United States, 83864
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
United States, Illinois
Saint Joseph Medical Center Active, not recruiting
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington Suspended
Bloomington, Illinois, United States, 61704
Illinois CancerCare-Canton Suspended
Canton, Illinois, United States, 61520
Memorial Hospital of Carbondale Suspended
Carbondale, Illinois, United States, 62902
SIH Cancer Institute Suspended
Carterville, Illinois, United States, 62918
Illinois CancerCare-Carthage Suspended
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic Suspended
Centralia, Illinois, United States, 62801
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: John W. Moroney    773-834-7424      
Principal Investigator: John W. Moroney         
Cancer Care Specialists of Central Illinois Suspended
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital Suspended
Decatur, Illinois, United States, 62526
Crossroads Cancer Center Suspended
Effingham, Illinois, United States, 62401
Illinois CancerCare-Eureka Suspended
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg Suspended
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center Suspended
Galesburg, Illinois, United States, 61401
Sudarshan K Sharma MD Limted-Gynecologic Oncology Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Sudarshan K. Sharma    630-654-1790    info@hhoaltd.com   
Principal Investigator: Sudarshan K. Sharma         
Illinois CancerCare-Kewanee Clinic Suspended
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb Suspended
Macomb, Illinois, United States, 61455
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
UC Comprehensive Cancer Center at Silver Cross Recruiting
New Lenox, Illinois, United States, 60451
Contact: John W. Moroney    773-834-7424      
Principal Investigator: John W. Moroney         
Illinois CancerCare-Ottawa Clinic Suspended
Ottawa, Illinois, United States, 61350
Radiation Oncology of Northern Illinois Suspended
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin Suspended
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Suspended
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois Suspended
Peoria, Illinois, United States, 61603
Illinois CancerCare-Peoria Suspended
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Suspended
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center Suspended
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru Suspended
Peru, Illinois, United States, 61354
Valley Radiation Oncology Suspended
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton Suspended
Princeton, Illinois, United States, 61356
Central Illinois Hematology Oncology Center Active, not recruiting
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine Suspended
Springfield, Illinois, United States, 62702
Springfield Clinic Suspended
Springfield, Illinois, United States, 62702
Memorial Medical Center Suspended
Springfield, Illinois, United States, 62781
Cancer Care Specialists of Illinois-Swansea Suspended
Swansea, Illinois, United States, 62226
Memorial and Saint Elizabeth's Health Care Services LLP Suspended
Swansea, Illinois, United States, 62226
United States, Indiana
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Michael J. Callahan    317-338-2194    research@stvincent.org   
Principal Investigator: Michael J. Callahan         
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: David P. Bender    800-237-1225      
Principal Investigator: David P. Bender         
United States, Kentucky
University of Kentucky/Markey Cancer Center Suspended
Lexington, Kentucky, United States, 40536
United States, Maryland
Sinai Hospital of Baltimore Suspended
Baltimore, Maryland, United States, 21215
MedStar Franklin Square Medical Center/Weinberg Cancer Institute Suspended
Baltimore, Maryland, United States, 21237
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Deborah K. Armstrong    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Deborah K. Armstrong         
United States, Michigan
University of Michigan Comprehensive Cancer Center Suspended
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital Active, not recruiting
Detroit, Michigan, United States, 48202
Green Bay Oncology - Escanaba Suspended
Escanaba, Michigan, United States, 49829
Green Bay Oncology - Iron Mountain Suspended
Iron Mountain, Michigan, United States, 49801
Borgess Medical Center Active, not recruiting
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital Active, not recruiting
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center Active, not recruiting
Kalamazoo, Michigan, United States, 49007
William Beaumont Hospital-Royal Oak Active, not recruiting
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital - Troy Active, not recruiting
Troy, Michigan, United States, 48098
United States, Mississippi
University of Mississippi Medical Center Active, not recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Central Care Cancer Center-Carrie J Babb Cancer Center Recruiting
Bolivar, Missouri, United States, 65613
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Parkland Health Center-Bonne Terre Suspended
Bonne Terre, Missouri, United States, 63628
Cox Cancer Center Branson Recruiting
Branson, Missouri, United States, 65616
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Saint Francis Medical Center Suspended
Cape Girardeau, Missouri, United States, 63703
Southeast Cancer Center Suspended
Cape Girardeau, Missouri, United States, 63703
Capital Region Medical Center-Goldschmidt Cancer Center Suspended
Jefferson City, Missouri, United States, 65109
Freeman Health System Recruiting
Joplin, Missouri, United States, 64804
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Mercy Hospital Joplin Recruiting
Joplin, Missouri, United States, 64804
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Delbert Day Cancer Institute at PCRMC Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Mercy Clinic-Rolla-Cancer and Hematology Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Saint Louis Cancer and Breast Institute-South City Recruiting
Saint Louis, Missouri, United States, 63109
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Washington University School of Medicine Suspended
Saint Louis, Missouri, United States, 63110
Missouri Baptist Medical Center Suspended
Saint Louis, Missouri, United States, 63131
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Sainte Genevieve County Memorial Hospital Suspended
Sainte Genevieve, Missouri, United States, 63670
Cancer Research for the Ozarks NCORP Terminated
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    888-221-4849      
Principal Investigator: Jay W. Carlson         
Missouri Baptist Sullivan Hospital Suspended
Sullivan, Missouri, United States, 63080
Missouri Baptist Outpatient Center-Sunset Hills Suspended
Sunset Hills, Missouri, United States, 63127
United States, Montana
Community Hospital of Anaconda Recruiting
Anaconda, Montana, United States, 59711
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Billings Clinic Cancer Center Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Saint Vincent Healthcare Suspended
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Saint James Community Hospital and Cancer Treatment Center Active, not recruiting
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Great Falls Clinic Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Saint Peter's Community Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Saint Patrick Hospital - Community Hospital Suspended
Missoula, Montana, United States, 59802
Community Medical Hospital Recruiting
Missoula, Montana, United States, 59804
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Peter C. Morris    402-354-5144      
Principal Investigator: Peter C. Morris         
United States, Nevada
Women's Cancer Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Nicola M. Spirtos    412-339-5294    Roster@nrgoncology.org   
Principal Investigator: Nicola M. Spirtos         
United States, New Jersey
Memorial Sloan Kettering Basking Ridge Active, not recruiting
Basking Ridge, New Jersey, United States, 07920
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Carolyn Y. Muller    505-925-0366    LByatt@nmcca.org   
Principal Investigator: Carolyn Y. Muller         
Southwest Gynecologic Oncology Associates Inc Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Carolyn Y. Muller    505-272-0530    RDraper@nmcca.org   
Principal Investigator: Carolyn Y. Muller         
United States, New York
Memorial Sloan Kettering Commack Active, not recruiting
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester Active, not recruiting
Harrison, New York, United States, 10604
Memorial Sloan-Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
Memorial Sloan Kettering Rockville Centre Active, not recruiting
Rockville Centre, New York, United States, 11570
Memorial Sloan Kettering Sleepy Hollow Active, not recruiting
Sleepy Hollow, New York, United States, 10591
Stony Brook University Medical Center Suspended
Stony Brook, New York, United States, 11794
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Linda Van Le    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Linda Van Le         
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Jubilee Brown    704-355-2884      
Principal Investigator: Jubilee Brown         
Carolinas HealthCare System NorthEast Recruiting
Concord, North Carolina, United States, 28025
Contact: Jubilee Brown    704-355-2884      
Principal Investigator: Jubilee Brown         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Angeles A. Secord    888-275-3853      
Principal Investigator: Angeles A. Secord         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Samuel S. Lentz    336-713-6771      
Principal Investigator: Samuel S. Lentz         
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Active, not recruiting
Akron, Ohio, United States, 44304
Strecker Cancer Center-Belpre Recruiting
Belpre, Ohio, United States, 45714
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
MetroHealth Medical Center Suspended
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Ohio State University Comprehensive Cancer Center Suspended
Columbus, Ohio, United States, 43210
Mount Carmel East Hospital Recruiting
Columbus, Ohio, United States, 43213
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
Columbus Oncology and Hematology Associates Inc Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
Columbus NCI Community Oncology Research Program Terminated
Columbus, Ohio, United States, 43215
Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
The Mark H Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Mount Carmel Health Center West Recruiting
Columbus, Ohio, United States, 43222
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Doctors Hospital Recruiting
Columbus, Ohio, United States, 43228
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Delaware Health Center-Grady Cancer Center Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Delaware Radiation Oncology Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Lancaster Radiation Oncology Terminated
Lancaster, Ohio, United States, 43130
OhioHealth Mansfield Hospital Recruiting
Mansfield, Ohio, United States, 44903
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
OhioHealth Marion General Hospital Recruiting
Marion, Ohio, United States, 43302
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Lake University Ireland Cancer Center Suspended
Mentor, Ohio, United States, 44060
Knox Community Hospital Recruiting
Mount Vernon, Ohio, United States, 43050
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: Timothy D. Moore    614-488-2745    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Newark Radiation Oncology Recruiting
Newark, Ohio, United States, 43055
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: Timothy D. Moore    614-488-2745    sheree@columbusccop.org   
Principal Investigator: Timothy D. Moore         
Springfield Regional Medical Center Active, not recruiting
Springfield, Ohio, United States, 45505
Saint Ann's Hospital Recruiting
Westerville, Ohio, United States, 43081
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Genesis Healthcare System Cancer Care Center Recruiting
Zanesville, Ohio, United States, 43701
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
Oklahoma Cancer Specialists and Research Institute-Tulsa Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Robert S. Mannel    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
United States, Oregon
Clackamas Radiation Oncology Center Suspended
Clackamas, Oregon, United States, 97015
Providence Oncology and Hematology Care Southeast Suspended
Clackamas, Oregon, United States, 97015
Providence Newberg Medical Center Suspended
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center Suspended
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center Suspended
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center Suspended
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Mark S. Shahin    215-481-2402      
Principal Investigator: Mark S. Shahin         
Lehigh Valley Hospital-Cedar Crest Suspended
Allentown, Pennsylvania, United States, 18103
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Geisinger Medical Center-Cancer Center Hazleton Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Geisinger Medical Oncology-Lewisburg Recruiting
Lewisburg, Pennsylvania, United States, 17837
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Lewistown Hospital Recruiting
Lewistown, Pennsylvania, United States, 17044
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Enrique Hernandez    215-728-4790      
Principal Investigator: Enrique Hernandez         
Temple University Hospital Suspended
Philadelphia, Pennsylvania, United States, 19140
Geisinger Medical Oncology-Pottsville Recruiting
Pottsville, Pennsylvania, United States, 17901
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Community Medical Center Recruiting
Scranton, Pennsylvania, United States, 18510
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Geisinger Medical Oncology-Selinsgrove Recruiting
Selinsgrove, Pennsylvania, United States, 17870
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Geisinger Medical Group Recruiting
State College, Pennsylvania, United States, 16801
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Geisinger Wyoming Valley/Henry Cancer Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Paul A. DiSilvestro    401-274-1122      
Principal Investigator: Paul A. DiSilvestro         
United States, South Dakota
Sanford Cancer Center Oncology Clinic Active, not recruiting
Sioux Falls, South Dakota, United States, 57104
Avera Cancer Institute Suspended
Sioux Falls, South Dakota, United States, 57105
Sanford USD Medical Center - Sioux Falls Active, not recruiting
Sioux Falls, South Dakota, United States, 57117-5134
United States, Texas
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: David S. Miller    214-590-5582      
Principal Investigator: David S. Miller         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: David S. Miller    214-590-5582      
Principal Investigator: David S. Miller         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Robert L. Coleman    713-792-3245      
Principal Investigator: Robert L. Coleman         
United States, Washington
PeaceHealth Saint John Medical Center Suspended
Longview, Washington, United States, 98632
PeaceHealth Southwest Medical Center Suspended
Vancouver, Washington, United States, 98664
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital Suspended
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital Cancer Center Green Bay Active, not recruiting
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital Suspended
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital Cancer Center at Saint Mary's Suspended
Green Bay, Wisconsin, United States, 54303
Aurora BayCare Medical Center Active, not recruiting
Green Bay, Wisconsin, United States, 54311
Holy Family Memorial Hospital Suspended
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center Active, not recruiting
Marinette, Wisconsin, United States, 54143
Aurora Saint Luke's Medical Center Active, not recruiting
Milwaukee, Wisconsin, United States, 53215
Green Bay Oncology - Oconto Falls Suspended
Oconto Falls, Wisconsin, United States, 54154
Saint Vincent Hospital Cancer Center at Sturgeon Bay Suspended
Sturgeon Bay, Wisconsin, United States, 54235-1495
Green Bay Oncology - Sturgeon Bay Suspended
Sturgeon Bay, Wisconsin, United States, 54235
Aurora West Allis Medical Center Active, not recruiting
West Allis, Wisconsin, United States, 53227
United States, Wyoming
Big Horn Basin Cancer Center Active, not recruiting
Cody, Wyoming, United States, 82414
Billings Clinic-Cody Recruiting
Cody, Wyoming, United States, 82414
Contact: Benjamin T. Marchello    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Welch Cancer Center Suspended
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jubilee Brown NRG Oncology

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01042522     History of Changes
Other Study ID Numbers: GOG-0264
NCI-2011-02000 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000662814
GOG-0264 ( Other Identifier: NRG Oncology )
GOG-0264 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Neoplasms
Sex Cord-Gonadal Stromal Tumors
Leydig Cell Tumor
Granulosa Cell Tumor
Sertoli-Leydig Cell Tumor
Neoplasms, Gonadal Tissue
Neoplasms by Histologic Type
Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Paclitaxel
Etoposide
Etoposide phosphate
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Bleomycin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents