S9912 Combination Chemo in Stage III Ovarian Cancer,

OBJECTIVES:

• Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer.
• Determine the feasibility of and toxic effects associated with this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

• Tumor involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis
• No tumors of borderline or low malignant potential only
• Mixed Mullerian tumors allowed
• Must have optimal disease defined as no residual lesions after resection or residual disease such that no single lesion measures greater than 1 cm in diameter
• Must have undergone staging exploratory laparotomy with tumor debulking within the past 70 days

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• SWOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic:

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• SGOT or SGPT ≤ 2 times ULN

Renal:

• Creatinine clearance ≥ 50 mL/min

Cardiovascular:

• No congestive heart failure
• No cardiac arrhythmia
• No myocardial infarction or unstable angina within the past 6 months
• Patients with a history of myocardial disease must not have ischemia or pathologic arrhythmias and must have an ejection fraction > 50% by MUGA

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No active or uncontrolled infection
• No concurrent fever
• No grade 2 or greater sensory neuropathy
• No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding, diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection
• No erythema or tenderness of abdominal incision or port site suggestive of underlying infection
• No other malignancy within the past five years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy for ovarian cancer

Chemotherapy:

• No prior chemotherapy for ovarian cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior pelvic radiotherapy for ovarian cancer

Surgery:

• See Disease Characteristics
• Recovered from all reversible surgery-related toxic effects

Other:

• No other concurrent antitumor treatment
• No concurrent antibiotics for infection of undetermined etiology