Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer

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.

DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial cancer of one of the following histologic
cell types:

- Serous adenocarcinoma

- Malignant Brenner's tumor

- Mucinous adenocarcinoma

- Endometrioid

- Adenocarcinoma

- Clear cell adenocarcinoma

- Undifferentiated carcinoma

- Transitional cell

- Mixed epithelial carcinoma

- Adenocarcinoma - not otherwise specified

- Meets 1 of the following criteria:

- Stage Ia or Ib, grade 3 or clear cell

- Stage Ic or II, all grades/histologies

- Complete surgical staging

- No tumors of low malignant potential (borderline tumors)

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-3

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times normal

- Alkaline phosphatase no greater than 3 times normal

- SGOT no greater than 3 times normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

- No major systemic medical illness expected to affect survival

- Body surface area no greater than 2.0

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

Other:

- No prior treatment for this malignancy except surgical staging

- No prior anticancer therapy that would preclude study participation