A phase II trial of didemnin B (NSC #335319) in patients with advanced squamous cell carcinoma of the cervix. A Gynecologic Oncology Group Study.

Didemnin B (NSC #335319) was administered i.v. to 26 evaluable patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix at 6.3 mg/m(2) every 28 days until progression of disease. No patient had had prior cytotoxic therapy alone. Some patients (4) were exposed to radiation sensitizers. There was one complete responder (4.5%). Six patients had stable disease (27.3%) and 15 (68.2%) had increasing disease. The toxicities were significant, with 11 patients (42.3%) experiencing grade 3 or 4 adverse effects. Didemnin B, when used with this dose and schedule, has minimal activity in squamous cell carcinoma of the cervix.