S9511: a Southwest Oncology Group phase II study of trimetrexate, 5-fluorouracil, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach.

Journal Article (Journal Article)

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 x 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.

Full Text

Duke Authors

Cited Authors

  • Blanke, CD; Chansky, K; Christman, KL; Hundahl, SA; Issell, BF; Van Veldhuizen, PJ; Budd, GT; Abbruzzese, JL; Macdonald, JS

Published Date

  • April 2010

Published In

Volume / Issue

  • 33 / 2

Start / End Page

  • 117 - 120

PubMed ID

  • 19770625

Pubmed Central ID

  • PMC2967385

Electronic International Standard Serial Number (EISSN)

  • 1537-453X

Digital Object Identifier (DOI)

  • 10.1097/COC.0b013e318199fb84


  • eng

Conference Location

  • United States