Paclitaxel in Treating Patients With Ovarian Stromal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Paclitaxel for Ovarian Stromal Tumors as First-Line or Second-Line Therapy|
- Frequency of complete clinical response [ Designated as safety issue: No ]
- Duration of progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||November 2000|
- Determine the clinical response to paclitaxel in patients with ovarian stromal cancer.
- Determine toxicity of this drug in these patients.
- Determine the value of inhibin for predicting response in these patients when treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment (yes vs no).
Patients receive paclitaxel 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.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.