Phase II trial of galactitol 1,2:5,6-dianhydro (NSC 132313) in the treatment of advanced gynecologic malignancies: a Gynecologic Oncology Group study.

Dianhydrogalactitol was administered intravenously to patients with advanced or recurrent gynecologic malignancies on a weekly schedule. The initial dosage was 60 mg/m2 with escalation to 75 mg/m2 if there were no adverse effects. Forty-two patients with ovarian epithelial adenocarcinoma (OEA) and forty-one patients with squamous carcinoma of the cervix (SCC) were entered into this study. Of these, 39 patients with OEA and 36 with SCC were evaluable for toxicity and response. Seven patients (19.4%) with SCC had an objective response, while six patients (15.4%) with OEA had an objective response. Adverse effects were frequent but tolerable. There were no drug-related deaths, and only two patients suffered life-threatening hematologic toxicity. Myelosuppression was observed more frequently among the patients with OEA. A higher percentage of OEA patients had received prior chemotherapy. The level of activity and frequency of adverse effects observed at this dose schedule warrant further studies of this drug in these two tumors.