Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

OBJECTIVES:

• Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma.
• Determine the response rate of patients treated with this regimen.
• Determine the time to progression and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma

• No tumors of low-malignant potential (borderline tumors)
• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2 OR
• Karnofsky 70-100%

Life expectancy:

• At least 6 months

Hematopoietic:

• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin greater than 10 g/dL

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal

Renal:

• Glomerular filtration rate at least 60 mL/min

Cardiovascular:

• No history of congestive heart failure (New York Heart Association class III or IV heart disease) even if medically controlled
• No myocardial infarction within the past 6 months
• No history of atrial or ventricular arrhythmias

Neurologic:

• No history of seizure disorder
• No history of CNS disorder
• No pre-existing motor or sensory neuropathy or symptoms grade 2 or greater

Other:

• No severe concurrent infection
• No prior hypersensitivity reaction to products containing Cremophor EL or compounds chemically related to carboplatin, paclitaxel, or gemcitabine
• No complete bowel obstruction
• No other concurrent severe medical problems that would preclude study
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy
• No concurrent WBC transfusions

Chemotherapy:

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except replacement therapy or steroid antiemetics

Radiotherapy:

• No prior radiotherapy
• No concurrent radiotherapy

Surgery:

• No more than 6 weeks since prior definitive surgery