A PHASE-II GYNECOLOGIC-ONCOLOGY-GROUP TRIAL OF IFOSFAMIDE AND MESNA IN ADVANCED OR RECURRENT ADENOCARCINOMA OF THE ENDOMETRIUM

In other Gynecologic Oncology Group (GOG) studies, ifosfamide demonstr ated antineoplastic activity against ovarian epithelial tumors, squamo us carcinomas of the cervix, uterine sarcomas, and trophoblastic disea se, Responses were also observed in 15% of patients with endometrial a denocarcinoma previously exposed to chemotherapy, This is a phase II t rial of ifosfamide in patients with chemotherapy-naive advanced or rec urrent endometrial adenocarcinoma, Thirty-seven patients with advanced adenocarcinoma of the endometrium recurrent after surgery and/or radi otherapy were treated with ifosfamide 1.2 g/m(2) intravenously daily f or 5 days every 4 weeks and mesna 300 mg/m(2) intravenously every 4 hr for 3 doses daily for 5 days with each course, Three patients were in eligible-one due to a second primary, one did not have an endometrial primary, and the other because of wrong cell type, One patient was ine valuable for response; thus, 33 were evaluable for response, All patie nts had undergone hysterectomy and 24 had received radiotherapy before entering the trial, Eleven had GOG performance status of 0, 18 had a status of 1, and 4 had performance status of 2, Median age was 68 year s (range, 41-86 years), Grade 3 or 4 neutropenia occurred in eight pat ients each and grade 3 thrombocytopenia was observed in one patient. O ne patient had a grade 4 neurotoxicity, Complete responses were observ ed in two patients (6.1%) and partial responses in six (18.2%) for an overall response rate of 24.3%, Ifosfamide in this dose and schedule i s an active drug in the treatment of patients with advanced or recurre nt adenocarcinoma of the endometrium. (C) 1996 Academic Press, Inc.