Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage 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. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma|
- Recurrence-free interval [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Frequency and severity of adverse events [ Designated as safety issue: Yes ]
|Study Start Date:||October 1998|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
- Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel.
- Assess the frequency and severity of toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks.
- Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo observation.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.
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|Study Chair:||Robert S. Mannel, MD||University of Oklahoma College of Medicine|
|Study Chair:||David S. Alberts, MD||University of Arizona|