Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Adult Type Ovarian Granulosa Cell Tumor
Ovarian Sertoli-Leydig Cell Tumor
Ovarian Sex Cord Tumor With Annular Tubules
Ovarian Steroid Cell Tumor
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy|
- Frequency of complete clinical response, assessed using GOG RECIST criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Duration of progression-free survival [ Time Frame: The period from study entry until disease progression, death or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: The observed length of life from entry into the study to death or the date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2000|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (paclitaxel)
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma.
II. To evaluate the value of inhibin for predicting response.
Patients receive paclitaxel intravenously (IV) over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, then every 6 months for three years, and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006227
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|Principal Investigator:||Linda Van Le||NRG Oncology|