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 2010



  • Chemotherapy
  • Gastric neoplasms
  • Trimetrexate

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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