Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors
Malignant Ovarian Surface Epithelial-Stromal Tumor
Biological: Bleomycin Sulfate
Drug: Etoposide Phosphate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 State and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary|
- Progression-free survival [ Time Frame: Date of randomization, and death due to any cause, assessed up to 10 years ] [ Designated as safety issue: No ]
- Tumor response rate [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]The relationship of treatment to tumor response rate will be assessed using logistic regression models adjusted for age and stratification factor (measurable disease status).
- Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]The relationship of treatment to overall survival will be assessed using the proportional hazards model.
|Study Start Date:||February 2010|
|Estimated Primary Completion Date:||January 2024 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other Names:Drug: Carboplatin
Given IVBiological: Bleomycin Sulfate
Experimental: Arm II
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
Other Names:Drug: Etoposide Phosphate
Other Names:Drug: Cisplatin
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.
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.
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: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042522
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|Principal Investigator:||Jubilee Brown||Gynecologic Oncology Group|