Phase II trial of edatrexate in patients with advanced pancreatic adenocarcinoma.

Journal Article (Clinical Trial;Journal Article)

BACKGROUND: The methotrexate analogue 10-ethyl-10-deazaaminopterin (10-EdAM, or edatrexate) has shown antitumor activity in preclinical testing and clinical studies of patients with breast, lung and head and neck carcinomas. A phase II study was conducted in patients with advanced pancreatic adenocarcinoma. PATIENTS AND METHODS: Forty patients were enrolled on the clinical trial. Edatrexate was administered intravenously at a dose of 80 mg/m2 weekly for 5 weeks. The treatment course was 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 dermatologic. Two patients experienced severe pulmonary toxic reactions. CONCLUSION: At the dose and schedule used, edatrexate was poorly tolerated and did not demonstrate significant antitumor activity.

Full Text

Duke Authors

Cited Authors

  • Moore, DF; Pazdur, R; Abbruzzese, JL; Ajani, JA; Dubovsky, DW; Wade, JL; Belt, RJ; Mangold, C; Bready, B; Winn, RJ

Published Date

  • March 1994

Published In

Volume / Issue

  • 5 / 3

Start / End Page

  • 286 - 287

PubMed ID

  • 8186177

International Standard Serial Number (ISSN)

  • 0923-7534

Digital Object Identifier (DOI)

  • 10.1093/oxfordjournals.annonc.a058810


  • eng

Conference Location

  • England