Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer

OBJECTIVES:

• Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse.
• Determine the response rates (complete and partial response) in patients treated with this regimen.
• Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses.

After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer

• Stage III or IV disease
• No borderline tumors
• Measurable or evaluable disease

• Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation
• Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)
• In first relapse

• Platinum-sensitive disease, defined as initial relapse > 6 months after completion of a platinum-based regimen

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

• Bilirubin normal
• Meets 1 of the following criteria:

• SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN
• SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal

Renal

• Creatinine ≤ 2.0 mg/dL
• Creatinine clearance > 50 mL/min

Cardiovascular

• LVEF ≥ 50%
• No poorly controlled arrhythmia
• No unstable coronary artery disease or myocardial infarction within the past year

Other

• HIV negative
• No pre-existing peripheral neuropathy > grade 2
• No history of allergy to study drugs

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• At least 3 weeks since prior radiotherapy and recovered

Surgery

• Recovered from recent prior surgery

Other

• No concurrent myelosuppressive therapy