Phase II study of Baker's antifol (triazinate, TZT, NSC-139,105) in advanced squamous cell carcinoma of cervix.

: Thirty-two evaluable patients with advanced cervical squamous cell carcinoma were treated with Baker's antifol in a phase II study by the Gynecologic Oncology Group (GOG). There were no complete responses and five partial responses for a response rate of 15.6%. Twenty patients remained stable during the course of therapy; seven had progressive disease. The median number of courses to response was four and the median duration of response was 3 months. The dose-limiting toxicity was dermatitis, which occurred in 10 patients. In four, dermatitis was severe with ulceration and/or desquamation. In two, dermatitis was life threatening and may have contributed to death. Half of the patients had mild or moderate GI side effects; in one case it was severe. Very little hematologic toxicity was observed. No cases of respiratory depression or arrest occurred with this regimen. Baker's antifol has some activity against cervical carcinoma and may be of interest for inclusion in studies of combination therapy because of its relative lack of myelotoxicity.