Phase II trial of edatrexate in relapsed or refractory germ cell tumors: ASouthwest Oncology Group study (SWOG 9124)

Up to 30% of patients with advanced germ cell tumors will fail induction ch emotherapy or will relapse. New agents with activity in this still potentia lly curable subgroup of patients are needed. Edatrexate (10-ethyl, 10-deaza -aminopterin) is a methotrexate analogue that has preclinical and clinical activity in breast, lung, and head and neck cancers, as well as in non-Hodg kin's lymphomas. A phase II trial of edatrexate in relapsed or refractory m alignant germ cell tumors was conducted by the Southwest Oncology Group (SW OG). Twenty-five patients were enrolled in the trial. Edatrexate was admini stered intravenously at a dose of 80 mg/m(2) weekly for four weeks followed by a one-week rest period. The treatment course was repeated every five we eks. Among the 23 patients evaluable for response, there were no objective responses with all patients developing progressive disease. Thirteen patien ts (56%) developed Grade 3-4 toxicities, predominantly stomatitis and malai se/fatigue/lethargy. One patient developed Grade 4 anemia while another dev eloped grade 4 anemia and thrombocytopenia. No patients discontinued treatm ent due to toxicity nor were there any toxic deaths. Edatrexate administere d in this dose and schedule has no antitumor activity and has substantial t oxicity in patients with relapsed or refractory germ cell tumors.