N-Methylformamide in advanced squamous cancer of the uterine cervix: An Eastern Cooperative Oncology Group phase II trial

Purpose: Preclinical and clinical data support the study of polar-planar co mpounds such as N-Methylformamide (NMF) in advanced squamous cell carcinoma of the uterine cervix (SCC). This phase II trial sought to determine the e fficacy and toxicities of NMF in patients with advanced SCC. Patients and m ethods: Eligibility for this trial required bidimensionally measurable squa mous or adenosquamous cell cancer of the uterine cervix incurable by surger y or radiation therapy, ECOG performance status of less than or equal to2, no prior NMF and no more than one prior chemotherapy regimen. Patients rece ived NMF at 2000 mg/m(2) intravenously over 15-30 minutes days 1, 8 and 15. The cycle was repeated every 42 days. A single dose escalation of 25%, 500 mg/m(2) was made after the first cycle if the toxicities did not exceed gr ade I for hepatic toxicity and grade II for nausea and vomiting. Results: F rom July 1987 through September 1998, 21 patients with advanced squamous ce ll carcinoma of the uterine cervix were entered on study. Two patients were ineligible because there was no pretreatment SGOT on one and the other det eriorated prior to drug approval. Therefore, 19 patients were include in th e analysis of response and survival. Four were inevaluable, 3 due to inappr opriate tumor evaluation and I secondary to grade III vomiting, who went of f study. These patients were included in the denominator while computing th e results. There were 2 deaths, one due to pulmonary hemorrhage from perfor ation during central venous insertion and one due to disease. 30% (6/19) pa tients had toxicities, Eastern Cooperative Oncology Group (ECOG) grade III or higher and 2 of these patients suffered multiple grade III toxicities. T here were no complete or partial responses. Conclusion: In this population, NMF in the dose and schedule employed exhibited no clinical activity.