• Maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel [ Designated as safety issue: Yes ]
  
• Feasibility of treatment [ Designated as safety issue: No ]
  

• Toxicity profile [ Designated as safety issue: Yes ]
  
• Response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel in patients with stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer who had initial debulking surgery.
• Determine the feasibility of this regimen in these patients.

Secondary

• Determine the toxicity profile of this regimen in these patients.
• Determine the response rate (in patients with measurable disease who are in the expanded cohort) and progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of intraperitoneal carboplatin.

Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-40 patients are treated at that dose level.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for dose escalation and 20-40 for feasibility) will be accrued for this study within 15 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer

  • Stage II-IV disease

• The following histologic epithelial cell types are eligible:

  • Serous adenocarcinoma
  • Mucinous adenocarcinoma
  • Clear cell adenocarcinoma
  • Transitional cell carcinoma
  • Adenocarcinoma not otherwise specified
  • Endometrioid adenocarcinoma
  • Undifferentiated carcinoma
  • Mixed epithelial carcinoma
  • Malignant Brenner's tumor
• Optimal (≤ 1 cm residual disease) OR suboptimal residual disease after initial debulking surgery (performed within the past 12 weeks)

• Synchronous primary endometrial cancer OR prior history of endometrial cancer allowed provided all of the following are true:

  • Stage IB disease or less
  • Less than 3 mm invasion without vascular or lymphatic invasion

  • No poorly differentiated subtypes, including the following:

    • Papillary serous
    • Clear cell
    • Other FIGO grade 3 lesions
• No epithelial tumors of low malignant potential (borderline tumors)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• No active bleeding

Hepatic

• AST ≤ 3 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 3 times ULN
• Bilirubin ≤ 1.5 times ULN
• No acute hepatitis

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No unstable angina
• No myocardial infarction within the past 6 months
• Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided the patient's cardiac status has been stable for at least 6 months before study entry

Other

• No neuropathy (sensory and motor) > grade 1
• No active infection requiring antibiotics
• No circumstances that would preclude study participation
• No other invasive malignancies within the past 5 years except non-melanoma skin cancer or localized breast cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 3 years since prior adjuvant chemotherapy for localized breast cancer

  • Patients must remain free of recurrent or metastatic disease

Endocrine therapy

• Not specified

Radiotherapy

• At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin

  • Patient must remain free of recurrent or metastatic disease
• No prior radiotherapy to any portion of the abdominal cavity or pelvis

Surgery

• See Disease Characteristics

Other

• No prior therapy for this malignancy
• No prior cancer treatment that contraindicates study therapy
• No concurrent amifostine or other protective agents