Phase II Trial of Trimetrexate (Neutrexin), 5-Fluorouracil and Leucovorin in Metastatic Colorectal Cancer
OBJECTIVES: I. Evaluate tumor response and duration, one-year progression-free survival, and
one-year overall survival in patients with recurrent or metastatic colorectal carcinoma when
treated with trimetrexate glucuronate, fluorouracil, and leucovorin calcium.
OUTLINE: Patients receive trimetrexate glucuronate (TMTX) IV over 1 hour on day 1. Beginning
18 hours after the TMTX dosage, patients receive leucovorin calcium (CF) IV over 2 hours.
Immediately after the completion of the CF infusion, patients receive an IV bolus injection
of fluorouracil (5-FU). Beginning 4 hours after the 5-FU infusion, patients receive oral CF
every 6 hours for 6 doses. Treatment repeats every 14 days in the absence of disease
progression or unacceptable toxicity or as long as the disease remains inoperable. Patients
are followed every 3 months for 1 year, every 6 months for 3 years, and then annually
PROJECTED ACCRUAL: A total of 18-45 patients will be accrued for this study within 15
Primary Purpose: Treatment
Juan Eduardo Perez, MD
Grupo Oncologico Cooperativo del Sur
United States: Federal Government