Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer

OBJECTIVES:

• Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian tube cancer treated with adjuvant carboplatin and paclitaxel with or without gemcitabine.
• Compare response rates, progression-free survival, and duration of response in patients treated with these regimens.
• Compare toxic effects of these regimens in these patients.
• Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
• Arm II: Patients receive carboplatin and paclitaxel as in arm I. Treatment in both arms repeats every 21 days for 6 to 10 courses in the absence of disease progression or unacceptable toxicity.

Some patients undergo interval debulking surgery.

Quality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12 months after completion of study.

Patients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,716 patients (858 per treatment arm) will be accrued for this study within 2 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of one of the following:

• Ovarian epithelial cancer

• FIGO stage IA/B G3, IC-IV
• Fallopian tube cancer
• Extra-ovarian papillary serous tumor
• The following are ineligible:

• Low malignant-potential ovarian tumors (borderline tumors)
• Non-epithelial ovarian tumors
• Mixed Mullerian tumors
• Must have had definitive surgery within the past 6 weeks
• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

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

Hepatic

• Bilirubin no greater than 2 times upper limit of normal

Renal

• Glomerular filtration rate at least 50 mL/min

Cardiovascular

• No congestive heart failure
• No myocardial infarction within the past 6 months
• No New York Heart Association class III or IV heart disease
• No prior atrial or ventricular arrhythmias

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior seizures or central nervous system disorder
• No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K)
• No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel
• No preexisting motor or sensory neuropathy greater than grade 1
• No other malignancy within the past 5 years except:

• Malignancies cured by surgery alone
• Carcinoma in situ of the cervix
• Adequately treated basal cell skin cancer
• No complete bowel obstruction
• No other concurrent severe medical condition that would preclude study participation
• No dementia or significantly altered mental status that would preclude study participation
• No concurrent severe active infection
• Geographically accessible for treatment and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy

Chemotherapy

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy except:

• Hormone replacement therapy
• Antiemetic steroids

Radiotherapy

• No prior radiotherapy
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• Recovered from prior surgery

Other

• No other concurrent antineoplastic agents
• No other concurrent investigational drugs
• No other concurrent clinical trial enrollment