Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer
- Conditions
- Ovarian Cancer
- Registration Number
- NCT00003449
- Lead Sponsor
- University of Southern California
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.
- Detailed Description
OBJECTIVES:
* Determine the response rate, progression time, and survival of patients with platinum-resistant ovarian cancer treated with weekly paclitaxel and gemcitabine.
* Determine the toxic effects of this regimen in these patients.
* Evaluate the toxic effects and safety profile of premedication with steroids with this regimen in these patients.
OUTLINE: Patients are stratified according to prior treatment with paclitaxel (none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel).
Patients receive dexamethasone IV, then paclitaxel IV followed by gemcitabine IV, for 3 consecutive weeks on days 1, 8, and 15. Treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity.
All patients are followed until death.
PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center and Hospital🇺🇸Los Angeles, California, United States