S9511: A southwest oncology group phase II study of trimetrexate, 5-fluorouracil, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach

Charles D. Blanke, Kari Chansky, Kathy L. Christman, Scott A. Hundahl, Brian F. Issell, Peter J. Van Veldhuizen, G. Thomas Budd, James L. Abbruzzese, John S. MacDonald

Research output: Contribution to journalArticle

4 Scopus citations


Objective: The primary objective of this trial was to evaluate the response rate for trimetrexate in conjunction with 5-FU and leucovorin (LV) (= TFL) in the treatment of advanced gastric cancer in a phase II, cooperative group setting. Methods: Patients with locally advanced, unresectable, or metastatic adenocarcinoma of the stomach received trimetrexate 110 mg/m IV over 60 minutes day 1, followed by 5-FU 500 mg/m IV bolus and LV 200 mg/m IV over 60 minutes day 2, followed by oral LV 15 mg every 6 hours × 7 doses, all weekly for 6 weeks followed by 2 weeks of rest, continued until progression. Results: Characteristics for 37 eligible patients: median age 63 (range: 23-83); male/female: 69% of 31%; performance status 0/1/2 15/20/1. The confirmed response rate was 19%, and median overall survival was 6 months. Two patients died as a result of therapy, 1 because of infection without significant neutropenia, and 1 due to perforation of a responding gastric lesion. Seventy-two percent experienced grades 3 and 4 toxicity, most commonly diarrhea, fatigue, and lymphopenia. Conclusions: This regimen achieves response rates comparable to other 5-FU-based regimens, when used in treatment of incurable gastric cancer. Toxicity appears manageable.

Original languageEnglish (US)
Pages (from-to)117-120
Number of pages4
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number2
StatePublished - Apr 1 2010



  • Chemotherapy
  • Gastric neoplasms
  • Trimetrexate

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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