A PHASE-II TRIAL OF PACLITAXEL IN PATIENTS WITH ADVANCED OR RECURRENTADENOCARCINOMA OF THE ENDOMETRIUM - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY

Objective: To determine the efficacy and toxicity of paclitaxel in adv anced 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 pa clitaxel, 250 mg/m(2), 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 receiv ed previous pelvic radiation were treated at an initial paclitaxel dos e of 200 mg/m(2). Twenty-eight patients were evaluable for response, a nd 29 patients for toxicity. All patients were Gynecologic Oncology Gr oup performance status 0, 1, or 2, Results: Complete responses were ob served 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 thrombocyt openia was seen in 18 and 2 patients, respectively. Grade 3 or 4 gastr ointestinal toxicity was seen in 5, neurotoxicity in 3, anemia in 2, a nd cardiac toxicity in 1. patients. Alopecia was reported in 16 patien ts. Conclusions: This dose and schedule of paclitaxel are active in pa tients with advanced or recurrent adenocarcinoma of the endometrium an d should be considered for inclusion in phase III trials. (C) 1996 Aca demic Press, Inc.