OBJECTIVES:

• Compare the overall survival, progression-free survival, and objective response rate (confirmed and unconfirmed, complete and partial) of patients with recurrent, persistent, or metastatic cervical cancer treated with cisplatin and paclitaxel vs cisplatin and gemcitabine.
• Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status at study entry (metastatic vs recurrent vs persistent), prior cisplatin as a radiosensitizer (yes vs no), and extent of disease (confined to pelvis vs extrapelvic disease). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 2 hours on day 2.
• Arm II:Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 4 years.

DISEASE CHARACTERISTICS:

• Diagnosis of primary carcinoma of the cervix, meeting 1 of the following staging criteria:

  • Metastatic (stage IVB)
  • Recurrent after prior complete response to primary treatment with surgery or radiotherapy
  • Persistent after surgery or radiotherapy
• Measurable disease

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Creatinine less than upper limit of normal OR
• Creatinine clearance greater than 40 mL/min

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No grade 2 or greater sensory or motor neuropathy
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 6 months since prior single-agent chemotherapy as a radiosensitizer

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• At least 28 days since prior radiotherapy
• No prior radiotherapy to measurable target lesions
• No concurrent palliative radiotherapy

Surgery

• See Disease Characteristics
• Recovered from prior surgery

Other

• No prior systemic therapy
• No other concurrent antitumor therapy