A PHASE-II TRIAL OF IFOSFAMIDE AND MESNA IN PATIENTS WITH ADVANCED ORRECURRENT MIXED MESODERMAL TUMORS OF THE OVARY PREVIOUSLY TREATED WITH PLATINUM-BASED CHEMOTHERAPY - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY

A phase II trial of ifosfamide and mesna in women with mixed mesoderma l tumors of the ovary who had previously received platinum-containing chemotherapy was conducted by the Gynecologic Oncology Group (GOG). Th e starting dose of ifosfamide was 1.2 g/m2 daily iv for 5 days. Mesna was given intravenously with and at 4 and 8 hr following the administr ation of ifosfamide. Each dose of mesna was 20% of the total daily dos e of ifosfamide. Thirty-two patients were placed on the study; 31 were evaluable for toxicity and 28 for response. Twenty-seven patients (87 .1%) had previously undergone surgery and three (9.3%) had received ra diotherapy before this trial. GOG grade 3 or 4 granulocytopenia occurr ed in 11 (35.5%) patients, and one (3.2%) developed grade 4 thrombocyt openia. Two patients (6.4%) had grade 3 neurotoxicity. A complete resp onse was observed in one patient (3.6%) and partial responses in four patients (14.3%) for a total response rate of 17.9% (95% confidence in terval = 6.1-36.9%). In conclusion, ifosfamide has activity in previou sly mixed mesodermal tumors of the ovary. (C) 1994 Academic Press, Inc .