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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

Trial Status: Active

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.

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

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Women's Cancer Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Oncology Centre
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871
Providence Alaska Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 907-212-6871

California

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 818-847-4793
Sylmar
Olive View-University of California Los Angeles Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 818-364-1555

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 720-848-0650

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

Georgia

Atlanta
Northside Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 404-303-3355
Augusta
Augusta University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 706-721-2388
Cumming
Northside Hospital-Forsyth
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 404-303-3355
Macon
Central Georgia Gynecologic Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 478-633-6090
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704
Memorial Health University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 912-350-7887

Idaho

Coeur D'Alene
Kootenai Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Post Falls
Kootenai Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Saint Joseph Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-457-5200
Carterville
SIH Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-985-3333
Carthage
Illinois CancerCare-Carthage
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Crossroads Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4740
Eureka
Illinois CancerCare-Eureka
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-570-2109
Galesburg
Illinois CancerCare-Galesburg
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-344-2831
Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-570-2109
Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-570-2109
Hinsdale
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-856-6757
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
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: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
O'Fallon
Cancer Care Center of O'Fallon
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Radiation Oncology of Northern Illinois
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
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
Springfield
Central Illinois Hematology Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-525-2500
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
Southwest Illinois Health Services LLP
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-236-1000

Indiana

Indianapolis
Saint Vincent Hospital and Health Care Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-338-2194

Iowa

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

Kansas

Coffeyville
Coffeyville Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 620-252-1606
Fairway
University of Kansas Clinical Research Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Hays
HaysMed University of Kansas Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 785-623-5774
Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Olathe
Olathe Health Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-355-8000
Pittsburg
Ascension Via Christi - Pittsburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 620-235-7900
Salina
Salina Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 785-452-7038
Topeka
University of Kansas Health System Saint Francis Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 785-295-8000
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-257-3379

Louisiana

New Orleans
University Medical Center New Orleans
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 410-955-8804
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

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Detroit
Henry Ford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-916-3721
Escanaba
Green Bay Oncology - Escanaba
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-433-8889
Iron Mountain
Green Bay Oncology - Iron Mountain
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Jonathan Edward Tammela
Phone: 920-433-8889
Kalamazoo
Borgess Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Bronson Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
West Michigan Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Royal Oak
William Beaumont Hospital-Royal Oak
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695
Troy
William Beaumont Hospital - Troy
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695

Mississippi

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

Missouri

Bolivar
Central Care Cancer Center - Bolivar
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-948-5588
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
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-556-3074
Kansas City
Truman Medical Centers
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-404-4375
University of Kansas Cancer Center - North
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
North Kansas City
University of Kansas Cancer Center at North Kansas City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-7504
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-7504
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: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
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
Billings
Billings Clinic Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Saint Vincent Healthcare
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Bozeman
Bozeman Deaconess Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Butte
Saint James Community Hospital and Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Helena
Saint Peter's Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Saint Patrick Hospital - Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-327-3118

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: 702-693-6870

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-639-7592

New Mexico

Albuquerque
Southwest Gynecologic Oncology Associates Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-272-0530
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

Commack
Memorial Sloan Kettering Commack
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-639-7592
New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-639-7592
Sleepy Hollow
Memorial Sloan Kettering Sleepy Hollow
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-639-7202
Stony Brook
Stony Brook University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-862-2215
Uniondale
Memorial Sloan Kettering Nassau
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-639-7592
West Harrison
Memorial Sloan Kettering Westchester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-639-7592

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-668-0683
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: 800-804-9376
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

Akron
Summa Health System - Akron Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 330-375-4221
Belpre
Strecker Cancer Center-Belpre
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Chillicothe
Adena Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-779-7585
Cleveland
Case Western Reserve University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Cleveland Clinic Cancer Center / Fairview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
MetroHealth Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 216-778-8526
Columbus
Columbus Oncology and Hematology Associates Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Doctors Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-3275
Grant Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
Mount Carmel East Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Mount Carmel Health Center West
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Riverside Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Delaware
Delaware Health Center-Grady Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-615-0227
Delaware Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Grady Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-615-2403
Dublin
Dublin Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-752-9119
Gahanna
Central Ohio Breast and Endocrine Surgery
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2745
Grove City
Mount Carmel Grove City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-779-7585
Lancaster
Fairfield Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-687-8863
Lancaster Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Mansfield
OhioHealth Mansfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-526-8018
Marietta
Marietta Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Marion
OhioHealth Marion General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Mount Vernon
Knox Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-393-9000
Newark
Licking Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-348-4000
Newark Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Portsmouth
Southern Ohio Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Springfield
Springfield Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-416-9270
Westerville
Saint Ann's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Zanesville
Genesis Healthcare System Cancer Care Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-454-5232

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777
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
Providence Cancer Institute Clackamas Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Newberg
Providence Newberg Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Oregon City
Providence Willamette Falls Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Portland
Providence Portland Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 503-215-2614

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
Danville
Geisinger Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-459-2901
Jefferson Hills
Jefferson Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-359-3043
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-374-8555
Lewistown
Lewistown Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 717-242-7703
Monroeville
Forbes Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-858-7746
Philadelphia
Fox Chase Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-275-6401
Scranton
Community Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-703-4768
Selinsgrove
Geisinger Medical Oncology-Selinsgrove
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-374-8555
State College
Geisinger Medical Group
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251
Wexford
Wexford Health and Wellness Pavilion
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 412-359-3043
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251

Rhode Island

Providence
Women and Infants Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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
Sanford Cancer Center Oncology Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 605-312-3320

Texas

Dallas
Parkland Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-590-5582
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-648-7097
Houston
M D Anderson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-632-6789

Washington

Longview
PeaceHealth Saint John Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-514-2016
Vancouver
PeaceHealth Southwest Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 360-514-3940

Wisconsin

Green Bay
Aurora BayCare Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Green Bay Oncology Limited at Saint Mary's Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Jonathan Edward Tammela
Phone: 920-433-8889
Green Bay Oncology at Saint Vincent Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Jonathan Edward Tammela
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center Green Bay
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-433-8889
Manitowoc
Holy Family Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-320-2749
Marinette
Bay Area Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Milwaukee
Aurora Saint Luke's Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304
Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-433-8889
Sturgeon Bay
Green Bay Oncology - Sturgeon Bay
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Jonathan Edward Tammela
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 920-433-8889
West Allis
Aurora West Allis Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 414-302-2304

Wyoming

Cody
Big Horn Basin Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Billings Clinic-Cody
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Sheridan
Welch Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

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 Phase II

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Jubilee Brown

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