Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial, fallopian
tube, or primary peritoneal cancer Must have undergone an initial exploratory laparotomy
with tumor debulking AND Must be FIGO stage IIIA, IIIB, IIIC, or IV at the time of initial
laparotomy Must have attained a clinically defined complete remission (CR) following
treatment with platinum (cisplatin or carboplatin) and paclitaxel based combination
chemotherapy regimen by achieving the following: No evidence of cancer on physical
examination CA-125 no greater than 35 units/mL Creatinine no greater than 2.0 mg/dL OR
Creatinine clearance greater than 60 mL/min Bilirubin no greater than 2.0 mg/dL Negative
ascites No evidence of residual cancer on CT scan of the abdomen/pelvis or chest x-ray (or
chest CT scan, if performed) No symptoms felt to be secondary to persistent malignancy
Must have received a minimum of 5 and a maximum of 6 courses of chemotherapy prior to
study Must register for study within 21 to 56 days after prior chemotherapy Not
concurrently registered to SWOG-S9618, SWOG-S9619, SWOG-S9912, or SWOG-S0009 or front line
treatment phase III GOG trials

PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: Granulocyte count at least 1,200/mm3 Platelet count at least
100,000/mm3 Hepatic: See Disease Characteristics Renal: See Disease Characteristics Other:
No prior malignancy within past 5 years except adequately treated basal cell or squamous
cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent antitumor treatment No
concurrent immunotherapy Chemotherapy: See Disease Characteristics Recovered from prior
chemotherapy Prior cisplatin allowed if initial dose at least 50 mg/m2 Prior carboplatin
allowed if initial dose at least 300 mg/m2 or AUC at least 4 No other concurrent
chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No concurrent
radiotherapy No prior abdominal/pelvic irradiation Surgery: See Disease Characteristics No
second look laparotomy or laparoscopy