Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of trimetrexate glucuronate, fluorouracil, and leucovorin in treating patients with recurrent or metastatic colorectal cancer.
Drug: leucovorin calcium
Drug: trimetrexate glucuronate
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Trimetrexate (Neutrexin), 5-Fluorouracil and Leucovorin in Metastatic Colorectal Cancer|
|Study Start Date:||December 1997|
|Study Completion Date:||August 2005|
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 thereafter.
PROJECTED ACCRUAL: A total of 18-45 patients will be accrued for this study within 15 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003446
|Grupo Oncologico Cooperativo del Sur|
|Bahia Blanca, Buenos Aires, Argentina, 8000|
|Study Chair:||Juan Eduardo Perez, MD||Grupo Oncologico Cooperativo del Sur|