Phase II study of Baker's antifol (triazinate, TZT, NSC 139, 105) in advanced carcinoma of the ovary

Summary

Twenty-nine patients with advanced ovarian carcinoma were entered into a Gynecologic Group Phase II study of Baker's Antifol. Of these, 26 were eligible for evaluation of toxicity and 25 for evaluation of response. The evaluable patients constituted an unusually favorable group for a Phase II study in a chemotherapy-sensitive tumor; although all have received prior chemotherapy, eight had had treatment with only a single alkylating agent and the median performance status of the study population was two (ambulatory, capable of self-care).

No complete responses were seen. Two patients had regression of abdominal tumor masses sufficient to qualify as partial responders (PR 8%). Dose-limiting toxicity, as expected, was found to be gastrointestinal. Significant mucositis and dermatitis were also observed. No episodes of hypotension during infusion occurred with a 60–120 min time of administration.

Baker's antifol has only limited activity against ovarian carcinoma previously treated with chemotherapy and is not likely to contribute to improved therapy, either as a single agent or in combination.