A PHASE-II TRIAL OF EDATREXATE IN PREVIOUSLY TREATED SQUAMOUS-CELL CERVICAL-CANCER - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY

A Phase II trial of edatrexate in patients with recurrent cervical car cinoma was conducted by the Gynecologic Oncology Group (GOG). Twenty p atients were treated with edatrexate at a dose of 80 mg/m(2) i.v. week ly for 5 consecutive weeks per cycle. Four patients received an inadeq uate trial and were inevaluable for response. Among the 16 patients ev aluable for response, there were no objective responses: 50% had stabl e disease, 50% had progressive disease. Ail 20 patients were evaluable for toxicity, predominantly stomatitis and bone marrow suppression we re substantial. Grades 3-4 bone marrow toxicity were observed in eight of 20 (40%) patients, and there were two deaths due to neutropenic se psis. Fanconi's syndrome, possibly treatment related, was seen in two patients. Edatrexate administered in this dose and schedule has no dem onstrated activity and has severe toxicity in patients with previously -treated advanced cervical cancer.