Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01042522|
Recruitment Status : Recruiting
First Posted : January 5, 2010
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Granulosa Cell Tumor Ovarian Gynandroblastoma Ovarian Sertoli-Leydig Cell Tumor Ovarian Sex Cord Tumor With Annular Tubules Ovarian Sex Cord-Stromal Tumor Ovarian Sex Cord-Stromal Tumor of Mixed or Unclassified Cell Types Ovarian Steroid Cell Tumor||Biological: Bleomycin Sulfate Drug: Carboplatin Drug: Cisplatin Drug: Etoposide Phosphate Other: Laboratory Biomarker Analysis Drug: Paclitaxel||Phase 2|
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: 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary|
|Actual Study Start Date :||February 8, 2010|
|Estimated Primary Completion Date :||January 2, 2024|
Experimental: Arm I (paclitaxel, carboplatin)
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:Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Paclitaxel
Experimental: Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)
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: Cisplatin
Other Names:Drug: Etoposide Phosphate
Other Name: EtopophosOther: Laboratory Biomarker Analysis
- Progression-free survival (PFS) [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 10 years ]The relationship of treatment to PFS will be assessed using the proportional hazards model.
- Overall survival (OS) [ Time Frame: From start of treatment to time of death or the date of last contact, assessed up to 10 years ]The relationship of treatment to overall survival will be assessed using the proportional hazards model.
- Tumor response rate [ Time Frame: Up to 10 years ]The relationship of treatment to tumor response rate will be assessed using logistic regression models adjusted for age and stratification factor (measurable disease status).
- Change in inhibin A and inhibin B levels [ Time Frame: Baseline to up to 2 years ]Pre-treatment levels of inhibin A and inhibin B will be examined in relation to OS and PFS in Cox proportional hazards models. Changes from baseline in inhibin levels will be compared between treatment groups using mixed effects models accounting for the longitudinal nature of the data. The repeated measures of inhibin will also be explored versus overall survival and PFS using time-dependent covariates in Cox proportional hazards models.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042522
Show 196 Study Locations
|Principal Investigator:||Jubilee Brown||NRG Oncology|