A phase II trial of weekly 1-hour paclitaxel as second-line therapy for endometrial and cervical cancer.

Background: The efficacy of weekly paclitaxel has not been well characterized in either cervical or endometrial cancer.

Methods: Eligible women had disseminated endometrial or squamous cell cancer of the cervix, one prior chemotherapy regimen, measurable disease, and a Gynecologic Oncology Group (GOG) performance status of 0-2. At entry, all laboratory results were within normal limits. Paclitaxel 80 mg/m(2) was administered by intravenous infusion over 1 h every 7 days. Response served as the endpoint of the trial.

Results: Forty-four patients were registered, and 15 of 16 patients with endometrial cancer and 20 of 28 patients with cervical cancer were evaluable for response. Four of the 15 (26.7%) endometrial cancer patients responded to treatment, with one complete response of 22 weeks and three partial responses. Stable disease was present in 26.7%. Two of the 20 (10%) cervical cancer patients responded to treatment, with one complete response of 25 weeks and one partial response of 14 weeks. Stable disease was present in 35%. Adverse effects were minimal and easily managed with dose adjustments as needed.

Conclusion: Although confirmatory larger trials are needed, weekly paclitaxel appears promising for advanced endometrial carcinoma, and possibly for squamous cell carcinoma of the cervix.