A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed stage III or IV ovarian epithelial or serous primary
peritoneal carcinoma

- The following are ineligible:

- Germ cell tumors

- Sex cord-stromal tumors

- Carcinosarcomas

- Mixed Mullerian tumors or carcinosarcomas

- Metastatic carcinomas from other sites to the ovary

- Low malignant potential tumors, including micropapillary serous carcinomas

- Mucinous primary peritoneal carcinoma

- Prior ovarian low malignant potential tumor (borderline carcinoma) that was
surgically resected with subsequent development of invasive adenocarcinoma allowed if
no prior chemotherapy

- Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery

- Prior breast cancer allowed provided the following are true:

- Disease-free for more than 5 years

- No prior cytotoxic chemotherapy for breast cancer

- Prior or concurrent primary endometrial cancer allowed if the following conditions
are met:

- Stage no greater than IB

- Less than 3 mm invasion without vascular or lymphatic invasion

- No poorly differentiated subtypes, including papillary serous, clear cell, or
other FIGO grade 3 lesions

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

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

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

- No acute hepatitis

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No unstable angina

- No myocardial infarction within the past 6 months

- No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block)
unless stable for the past 6 months

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No greater than grade 1 sensory or motor neuropathy

- No active infection that requires antibiotics

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

- No severe or ongoing gastrointestinal bleeding that requires blood product support

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed
provided the following are true:

- More than 3 years since prior therapy

- No evidence of recurrent disease

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to any portion of the abdominal cavity or pelvis

- Prior radiotherapy for localized breast, head and neck, or skin cancer allowed
provided the following are true:

- More than 3 years since prior therapy

- No evidence of recurrent disease

Surgery:

- See Disease Characteristics

- No more than 12 weeks since prior surgical resection