Phase II trial of ZD1694 (Tomudex) in patients with advanced pancreatic cancer.


Journal Article

Currently available therapies for advanced pancreatic cancer offer only palliative benefits, and patients with this disease have a poor prognosis. We undertook a phase II trial of ZD1694 (Tomudex), a quinazoline folate analogue that is a potent and selective thymidylate synthase inhibitor, to determine this analogue's efficacy and safety in patients with advanced pancreatic adenocarcinoma.ZD1694, 3.0 mg/m2, was administered to 42 adult patients with pancreatic adenocarcinoma as a 15-minute intravenous infusion every 3 weeks for up to 6 doses. Objective tumor response was assessed every 6 weeks; clinical examinations, adverse event assessments, and clinical laboratory tests were performed every 3 weeks.ZD1694 produced an overall response rate of 5% (95% confidence limits [CI], 1% to 16%) in the study group. Of 42 patients, 2 (5%) had a partial response, 12 (29%) had stable disease, 21 (50%) had disease progression, and 5 (11%) could not be evaluated for response. Grade 3 vomiting, grades 3 and 4 fever, grade 3 leukopenia, grade 4 thrombocytopenia, and grades 3 and 4 liver function elevations were reported. Toxic effects with ZD1694 were reversible and manageable.ZD1694 has an acceptable safety profile but limited activity in patients with advanced pancreatic cancer.

Full Text

Duke Authors

Cited Authors

  • Pazdur, R; Meropol, NJ; Casper, ES; Fuchs, C; Douglass, HO; Vincent, M; Abbruzzese, JL

Published Date

  • January 1, 1996

Published In

Volume / Issue

  • 13 / 4

Start / End Page

  • 355 - 358

PubMed ID

  • 8824356

Pubmed Central ID

  • 8824356

Electronic International Standard Serial Number (EISSN)

  • 1573-0646

International Standard Serial Number (ISSN)

  • 0167-6997

Digital Object Identifier (DOI)

  • 10.1007/bf00873144


  • eng