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.