Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer
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.
|Ovarian Cancer||Drug: dexamethasone Drug: gemcitabine hydrochloride Drug: paclitaxel||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer|
|Study Start Date:||May 1998|
|Study Completion Date:||February 2004|
|Primary Completion Date:||June 2002 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003449
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033-0804|
|Study Chair:||Agustin Garcia, MD||University of Southern California|