OBJECTIVES:
* 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.
