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.