A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: A Gynecologic Oncology Group Study

Objective: To determine the efficacy and toxicity of paclitaxel in advanced or recurrent adenocarcinoma of the endometrium. Methods: Thirty patients with advanced or recurrent endometrial cancer with measurable disease not previously treated with chemotherapy were treated with paclitaxel, 250 mg/m², over 24 hr with G-CSF, 5 mcg/kg/day, from Days 2 to 12. The cycle was repeated every 21 days. Patients who had received previous pelvic radiation were treated at an initial paclitaxel dose of 200 mg/m². Twenty-eight patients were evaluable for response, and 29 patients for toxicity. All patients were Gynecologic Oncology Group performance status 0, 1, or 2. Results: Complete responses were observed in 4 (14.3%) and partial responses in 6 patients (21.4%) for a response rate of 35.7%. Severe (grade 3 or 4) leukopenia or thrombocytopenia was seen in 18 and 2 patients, respectively. Grade 3 or 4 gastrointestinal toxicity was seen in 5, neurotoxicity in 3, anemia in 2, and cardiac toxicity in 1 patients. Alopecia was reported in 16 patients. Conclusions: This dose and schedule of paclitaxel are active in patients with advanced or recurrent adenocarcinoma of the endometrium and should be considered for inclusion in phase III trials.