Phase II study of ifosfamide and mesna in nonsquamous carcinoma of the cervix: a Gynecologic Oncology Group study.

A phase II trial of ifosfamide (IFX) and mesna was conducted by the GOG in patients with recurrent or advanced nonsquamous carcinoma of the cervix. A starting dose of 1.5 g/m2 IFX iv daily for 5 days and 300 mg/m2 mesna iv every 4 hr with three doses daily after IFX were given. In patients who had received prior radiotherapy or chemotherapy, the starting dose of IFX was reduced to 1.2 g/m2. Forty-six patients were entered, and 41 are evaluable for toxicity. Forty patients are evaluable for response. Age range was 30-72 yr. GOG performance status was 0-1 for all but 2 patients. Fifteen patients (37.5%) developed GOG grade 3 or 4 granulocytopenia, and 1 developed grade 4 thrombocytopenia. One patient developed transient renal insufficiency. There was one complete response and five partial responses (12.5%) for a response rate of 15.0%. Median response duration was 4.2 months (range, 1.7-22.6 months). Three responses were seen in areas with pelvic disease only. Three responses were observed in extrapelvic sites. IFX possesses activity which compares favorably with that of other agents in this disease.