Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00003449|
Recruitment Status : Completed
First Posted : September 24, 2003
Last Update Posted : May 22, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: dexamethasone Drug: gemcitabine hydrochloride Drug: paclitaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Official Title:||Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer|
|Study Start Date :||May 1998|
|Actual Primary Completion Date :||June 2002|
|Actual Study Completion Date :||February 2004|
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): 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|