Eastern Cooperative Oncology Group, phase I trial of protracted venous infusion fluorouracil plus weekly gemcitabine with concurrent radiation therapy in patients with locally advanced pancreas cancer: A regimen with unexpected early toxicity

Mark S. Talamonti*, Paul J. Catalano, David J. Vaughn, Richard Whittington, R. Danie Beauchamp, Jordan Berlin, Al B. Benson

*Corresponding author for this work

Research output: Contribution to journalArticle

113 Scopus citations

Abstract

Purpose: We preformed a phase I trial of protracted venous infusion (PVI) fluorouracil (5-FU) plus weekly gemcitabine with concurrent radiation therapy in patients with locally advanced pancreas cancer to determine the maximum-tolerated dose of gemcitabine that could be safely administered. We also sought to identify the toxicities associated with this treatment protocol. Patients and Methods: Seven patients with locally advanced pancreas cancer were treated with planned doses of radiation (59.4 Gy) and PVI of 5-FU (200 mg/m2/d) with gemcitabine doses of 50 to 100 mg/ m2/wk. Results: Two of three patients at the 100-mg/m2/wk dose level experienced dose-limiting toxicity (DLT), as did three of four at the 50-mg/m2/wk dose level. One patient experienced a mucocutaneous reaction described as a Stevens-Johnson syndrome that was attributed chemotherapy. Three patients developed gastric or duodenal ulcers with severe bleeding requiring transfusion. One patient developed severe thrombocytopenia lasting longer than 4 weeks. Three of the five episodes of DLT developed at radiation doses ≤ 36 Gy. Conclusion: Based on this experience, we cannot recommend further investigation of regimens incorporating gemcitabine into regimens of radiation with PVI 5-FU. The mechanism of this synergistic toxicity remains to be determined. (C) 2000 by American Society of Clinical Oncology.

Original languageEnglish (US)
Pages (from-to)3384-3389
Number of pages6
JournalJournal of Clinical Oncology
Volume18
Issue number19
DOIs
StatePublished - Oct 1 2000

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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