OBJECTIVES:

• Determine the response rate of patients with newly diagnosed, debulked stage III/IV ovarian epithelial cancer treated with dose-intensive paclitaxel/cisplatin/cyclophosphamide with filgrastim (G-CSF).
• Characterize the toxic effects of this regimen in these patients.
• Analyze molecular markers of DNA damage repair and genetic risk in ovarian cancer tissue samples, with cytogenetic assessment performed where available.
• Correlate molecular marker results with response to therapy, tumor type, and survival.

OUTLINE: This is a multicenter study.

Patients receive cyclophosphamide IV over 15 minutes followed immediately by paclitaxel IV over 24 hours on day 1. Cisplatin IV over 1 hour is administered on day 2 for 6 courses only. Filgrastim (G-CSF) is administered subcutaneously on days 3-11. Treatment repeats every 21 days for at least 6 courses.

Patients who achieve a complete response proceed to laparoscopy or second look laparotomy, then receive 2 more courses of chemotherapy. Patients with partial response or stable disease continue to receive cyclophosphamide and paclitaxel, with restaging every 2 courses. Patients with bulky residual disease proceed to interim debulking surgery after 8 courses of chemotherapy.

Patients are followed every 3 months for 3 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 80 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically proven, newly diagnosed, ovarian epithelial cancer, primary epithelial fallopian tube cancer, or primary peritoneal carcinoma
• Stage III or IV disease
• No CNS involvement
• Surgical debulking attempted prior to chemotherapy
• No germ cell tumors
• No mixed Muellerian or borderline tumors

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal
• PT and PTT normal

Renal:

• Creatinine clearance at least 60 mL/min
• Correction of ureteral obstruction required prior to therapy

Cardiovascular:

• No history of myocardial infarction or unstable dysrhythmia within 1 month

Other:

• No history of active gastrointestinal bleeding within 30 days
• No history of invasive malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy for this malignancy

Chemotherapy

• No prior chemotherapy for this malignancy

Endocrine therapy

• No prior endocrine therapy for this malignancy

Radiotherapy

• No prior radiotherapy for this malignancy

Surgery

• Prior surgery for this malignancy allowed