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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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.
PURPOSE: This randomized phase II trial is studying paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with advanced or recurrent sex cord-ovarian stromal tumors.
- 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 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.
Allocation: Randomized, Primary Purpose: Treatment
bleomycin sulfate, carboplatin, cisplatin, etoposide phosphate, paclitaxel
Providence Saint Joseph Medical Center - Burbank
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:10:27-0400
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