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

Frederick J Meyers, Danika Lew, Primo N Lara, Steve Williamson, Ernest Marshall, Stanley P. Balcerzak, Saul E. Rivkin, Wolfram Samlowski, E. David Crawford

Research output: Contribution to journalArticlepeer-review

5 Scopus citations


Up to 30% of patients with advanced germ cell tumors will fail induction chemotherapy or will relapse. New agents with activity in this still potentially 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-Hodgkin's lymphomas. A phase II trial of edatrexate in relapsed or refractory malignant germ cell tumors was conducted by the Southwest Oncology Group (SWOG). Twenty-five patients were enrolled in the trial. Edatrexate was administered intravenously at a dose of 80 mg/m2 weekly for four weeks followed by a one-week rest period. The treatment course was repeated every five weeks. Among the 23 patients evaluable for response, there were no objective responses with all patients developing progressive disease. Thirteen patients (56%) developed Grade 3-4 toxicities, predominantly stomatitis and malaise/fatigue/lethargy. One patient developed Grade 4 anemia while another developed grade 4 anemia and thrombocytopenia. No patients discontinued treatment due to toxicity nor were there any toxic deaths. Edatrexate administered in this dose and schedule has no antitumor activity and has substantial toxicity in patients with relapsed or refractory germ cell tumors.

Original languageEnglish (US)
Pages (from-to)347-351
Number of pages5
JournalInvestigational New Drugs
Issue number4
StatePublished - 1998


  • Chemotherapy
  • Edatrexate
  • Germ cell tumors
  • Salvage

ASJC Scopus subject areas

  • Molecular Medicine
  • Pharmacology


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