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
OBJECTIVES:
Primary
- 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.
Secondary
- 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
1-4.
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Progression-free survival
No
Jubilee Brown, MD
Principal Investigator
M.D. Anderson Cancer Center
Unspecified
CDR0000662814
NCT01042522
February 2010
Name | Location |
---|---|
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 |