ALTRETAMINE (HEXAMETHYLMELAMINE) IN PLATINUM-RESISTANT AND PLATINUM-REFRACTORY OVARIAN-CANCER - A GYNECOLOGIC-ONCOLOGY-GROUP PHASE-II TRIAL

Objectives, In an effort to critically examine the antitumor activity of altretamine (hexamethylmelamine) as salvage therapy of platinum-ref ractory ovarian cancer, the Gynecologic Oncology Group initiated a Pha se II trial of the agent administered in this clinical setting, Method s. Altretamine was administered at a dose of 260 mg/m(2) orally for 14 days in a 28-day course. Treatment was continued until disease progre ssion or unacceptable side effects prevented further therapy. A total of 36 patients (median age: 56.5) were treated on this trial, of whom 33 were evaluable for toxicity and 30 for response. All patients had p reviously received either cisplatin or carboplatin and paclitaxel. Res ults, The major side effect was emesis (grade 3-4, 7/33, 21%), The obj ective response rate was 10% (one complete response, two partial respo nses), Conclusion. We conclude that altretamine has limited activity i n platinum-refractory ovarian cancer. (C) 1998 Academic Press.