PHASE-II TRIAL OF EDATREXATE IN PATIENTS WITH ADVANCED PANCREATIC ADENOCARCINOMA

Background: The methotrexate analogue 10-ethyl-10-deazaaminopterin (10 -EdAM, or edatrexate) has shown antitumor activity in preclinical test ing and clinical studies of patients with breast, lung and head and ne ck carcinomas. A phase II study was conducted in patients with advance d pancreatic adenocarcinoma. Patients and methods: Forty patients were enrolled on the clinical trial. Edatrexate was administered intraveno usly at a dose of 80 mg/m2 weekly for 5 weeks. The treatment course wa s repeated every 6 weeks. Results: Two partial responses were observed . Both of these patients had partial responses which lasted 2 and 3.5 months. The median survival for all patients was 3.5 months. Serious ( grade 3 or 4) toxic effects were primarily mucosal, hematologic, and d ermatologic. Two patients experienced severe pulmonary toxic reactions . Conclusion: At the dose and schedule used, edatrexate was poorly tol erated and did not demonstrate significant antitumor activity.