Paclitaxel in Treating Patients With Ovarian Stromal Cancer
|ClinicalTrials.gov Identifier: NCT00006227|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Adult Type Ovarian Granulosa Cell Tumor Ovarian Gynandroblastoma Ovarian Sertoli-Leydig Cell Tumor Ovarian Sex Cord Tumor With Annular Tubules Ovarian Steroid Cell Tumor||Drug: Paclitaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy|
|Actual Study Start Date :||November 20, 2000|
|Actual Primary Completion Date :||July 16, 2016|
|Actual Study Completion Date :||July 16, 2016|
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.
- Frequency of complete clinical response, assessed using GOG RECIST criteria [ Time Frame: Up to 5 years ]
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006227
Show 98 Study Locations
|Principal Investigator:||Linda Van Le||NRG Oncology|