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Annals of Oncology 13:582-588, 2002
© 2002 European Society for Medical Oncology

Original Paper

Low-dose trimetrexate glucuronate and protracted 5-fluorouracil infusion in previously untreated patients with advanced pancreatic cancer

R. G. Amado+, L. S. Rosen, J. R. Hecht, L.-S. Lin and P. J. Rosen

Division of Hematology/Oncology and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, CA, USA

Received 18 June 2001; revised 26 September 2001; accepted 16 October 2001.

Background

5-Fluorouracil (5-FU)-based regimens have not been shown to prolong survival or provide clinical benefit in patients with advanced pancreatic cancer. The purpose of this study was to determine the tolerability of protracted venous infusion (PVI) of 5-FU, modulated by a low dose of the synthetic antifolate trimetrexate, in patients with advanced pancreatic cancer.

Patients and methods

Twenty-three chemotherapy-naïve patients were evaluated. Patients were enrolled in four consecutive cohorts in which the weekly dose of trimetrexate was escalated in 10 mg/m2 increments, from 20 to 50 mg/m2. PVI 5-FU was administered at a fixed dose of 225 mg/m2/day. Treatment was administered for 6 successive weeks, every 8 weeks.

Results

Twenty-two patients were assessable. The maximum tolerated dose of trimetrexate was 40 mg/m2. The most common grade 3 and 4 toxicity was diarrhea. There were no treatment-related deaths. Preliminary analysis of activity revealed a response rate of 9%, with 41% of the patients having stable disease for a median duration of 3.8 months. The median survival for the entire group was 6.9 months (range 1–29 months). A clinical benefit response was experienced by 27.2% of patients.

Conclusions

Low-dose trimetrexate can be safely administered in combination with PVI 5-FU. This treatment is well tolerated and is associated with palliative activity in advanced pancreatic cancer.

Key words: antifolates, 5-fluorouracil, 5-FU modulation, infusional 5-FU, pancreatic cancer, trimetrexate


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