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.
