Phase II study of N-methylformamide (N-MF) (NSC 3051) in patients with advanced squamous cancer of the cervix - A Gynecologic Oncology Group study

Twenty patients with advanced measurable, squamous carcinoma of the cervix were treated with 25 courses of N-MF at doses ranging from 600-800 mg/m², intravenously, daily for 5 days every 28 days. Nineteen patients are evaluable for toxicity and 17 for response. All patients had prior radiation and had received one prior chemotherapy regimen while only 10 patients had had prior surgery. All patients were Gynecologic Oncology Group (GOG) performance status 0, 1, or 2. No responses were seen. Hematologic adverse effects were extremely rare as predicted by early clinical trials. One unusual toxicity was a syndrome consisting of pain, anorexia, lethargy, and declining performance status (pain/lethargy syndrome) that was reversible with discontinuation of the drug. This adverse effect was a reason for discontinuation of N-MF in two patients. As reported in previous studies with this drug, hepatic toxicity was also common, usually reversible, and also a cause for discontinuation of the drug. The lack of clinical activity and the unpleasant adverse effects in this population of patients with previously treated cervix cancer makes it unlikely that this drug will play any significant role in treatment.