A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced State and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary
- To compare the progression-free survival of patients with advanced or recurrent sex
cord-stromal tumors of the ovary treated with paclitaxel and carboplatin versus
bleomycin sulfate, etoposide phosphate, and cisplatin.
- To estimate the toxicity of these regimens in this patient population.
- To compare the overall survival of patients treated with these regimens.
- To evaluate response rate in a subset of patients with measurable disease.
- To collect fixed and/or frozen tumor tissue for future translational research studies.
- 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
in response to treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to presence of
measurable disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: 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.
- 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
Patients undergo blood sample collection at baseline and periodically during study for
laboratory biomarker analysis.
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.
Allocation: Randomized, Primary Purpose: Treatment
Jubilee Brown, MD
M.D. Anderson Cancer Center
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Bronson Methodist Hospital||Kalamazoo, Michigan 49007|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Borgess Medical Center||Kalamazooaa, Michigan 49001|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|MetroHealth Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44109|
|Sanford Cancer Center at Sanford USD Medical Center||Sioux Falls, South Dakota 57117-5039|
|CCOP - Cancer Research for the Ozarks||Springfield, Missouri 65807|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Hulston Cancer Center at Cox Medical Center South||Springfield, Missouri 65807|
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|Alvin and Lois Lapidus Cancer Institute at Sinai Hospital||Baltimore, Maryland 21215|
|Stony Brook University Cancer Center||Stony Brook, New York 11794-8174|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|St. Vincent Hospital Regional Cancer Center||Green Bay, Wisconsin 54307-3508|
|Green Bay Oncology, Limited - Escanaba||Escanaba, Michigan 49431|
|Dickinson County Healthcare System||Iron Mountain, Michigan 49801|
|St. Mary's Hospital Medical Center - Green Bay||Green Bay, Wisconsin 54303|
|Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center||Green Bay, Wisconsin 54301-3526|
|Green Bay Oncology, Limited at St. Mary's Hospital||Green Bay, Wisconsin 54303|
|Bay Area Cancer Care Center at Bay Area Medical Center||Marinette, Wisconsin 54143|
|Green Bay Oncology, Limited - Oconto Falls||Oconto Falls, Wisconsin 54154|
|Green Bay Oncology, Limited - Sturgeon Bay||Sturgeon Bay, Wisconsin 54235|
|Riverside Methodist Hospital Cancer Care||Columbus, Ohio 43214|
|Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center||Savannah, Georgia 31403-3089|
|Lucille P. Markey Cancer Center at University of Kentucky||Lexington, Kentucky 40536-0093|
|University of Mississippi Cancer Clinic||Jackson, Mississippi 39216-4505|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|University of New Mexico Cancer Center||Albuquerque, New Mexico 87131-5636|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Methodist Estabrook Cancer Center||Omaha, Nebraska 68114-4199|
|Cleveland Clinic Cancer Center at Fairview Hospital||Cleveland, Ohio 44111|
|Hillcrest Cancer Center at Hillcrest Hospital||Mayfield Heights, Ohio 44124|
|Cancer Care Associates - Saint Francis Campus||Tulsa, Oklahoma 74136-1929|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest||Allentown, Pennsylvania 18105|
|Parkland Memorial Hospital||Dallas, Texas 75235|
|Holy Family Memorial Medical Center Cancer Care Center||Manitowoc, Wisconsin 54221-1450|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|
|Regional Cancer Center at Memorial Medical Center||Springfield, Illinois 62781-0001|
|Duke Cancer Institute||Durham, North Carolina 27710|
|Gynecologic Oncology||Hinsdale, Illinois 60521|
|Women's Cancer Center - La Canada||Las Vegas, Nevada 89169|
|Olive View - UCLA Medical Center Foundation||Sylmar, California 91342|
|Central Georgia Gynecologic Oncology||Macon, Georgia 31201|
|Southwest Gynecologic Oncology Associates, Incorporated||Albuquerque, New Mexico 87102|
|Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center||Burbank, California 91505|
|St. Vincent Oncology Center||Indianapolis, Indiana 46260|