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

Abstract

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.

• Authors: Charles D Blanke, Kari Chansky, Kathy L Christman, Scott A Hundahl, Brian F Issell, Peter J Van Veldhuizen Jr, G Thomas Budd, James L Abbruzzese, John S Macdonald
• Journal: American journal of clinical oncology (Am J Clin Oncol) Vol. 33 Issue 2 Pg. 117-20 (Apr 2010) ISSN: 1537-453X [Electronic] United States
• PMID: 19770625 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Leucovorin
• Fluorouracil
• Trimetrexate

Topics

• Adenocarcinoma (drug therapy, secondary)
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Female
• Fluorouracil (administration & dosage)
• Humans
• Leucovorin (administration & dosage)
• Male
• Middle Aged
• Neoplasm Staging
• Stomach Neoplasms (drug therapy, pathology)
• Survival Rate
• Treatment Outcome
• Trimetrexate (administration & dosage)
• Young Adult