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 studyof polar-planar compounds such as N-Methylformamide (NMF) inadvanced squamous cell carcinoma of the uterine cervix (SCC).This phase II trial sought to determine the efficacy andtoxicities of NMF in patients with advanced SCC. Patientsand methods: Eligibility for this trial requiredbidimensionally measurable squamous or adenosquamous cellcancer of the uterine cervix incurable by surgery or radiationtherapy, ECOG performance status of ≤2, no prior NMF and nomore than one prior chemotherapy regimen. Patients receivedNMF at 2000 mg/m2 intravenously over 15–30 minutes days 1,8 and 15. The cycle was repeated every 42 days. A single doseescalation of 25%, 500 mg/m2 was made after the firstcycle if the toxicities did not exceed grade I for hepatictoxicity and grade II for nausea and vomiting. Results:From July 1987 through September 1998, 21 patients withadvanced squamous cell carcinoma of the uterine cervix wereentered on study. Two patients were ineligible because therewas no pretreatment SGOT on one and the other deterioratedprior to drug approval. Therefore, 19 patients were include inthe analysis of response and survival. Four were inevaluable,3 due to inappropriate tumor evaluation and I secondary tograde III vomiting, who went off study. These patients wereincluded in the denominator while computing the results. Therewere 2 deaths, one due to pulmonary hemorrhage fromperforation during central venous insertion and one due todisease. 30% (6/19) patients had toxicities, EasternCooperative Oncology Group (ECOG) grade III or higher and 2 ofthese patients suffered multiple grade III toxicities. Therewere no complete or partial responses. Conclusion: Inthis population, NMF in the dose and schedule employedexhibited no clinical activity.