Paclitaxel in Treating Patients With Ovarian Stromal Cancer
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|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|
|Primary Completion Date :||July 16, 2016|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006227
Show 98 Study Locations
|Principal Investigator:||Linda Van Le||NRG Oncology|