Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
- Research the oncogenetic parameters and pharmacogenetic and pharmacokinetic predictors
of therapeutic response and toxic effects.
- Study the correlations between the pharmacogenetic and pharmacokinetic parameters.
- Study the predictive value of these parameters on disease-free and overall survival.
OUTLINE: This is a multicenter study.
Patients receive 1 of 4 chemotherapy regimens:
- Regimen 1: Fluorouracil and leucovorin calcium
- Regimen 2: Capecitabine and leucovorin calcium
- Regimen 3: Irinotecan hydrochloride
- Regimen 4: Oxaliplatin Tumor and blood samples are collected before the start of
chemotherapy and are examined by pharmacogenetic analysis. Clinical and biological
parameters are also studied. Blood samples are also collected during the first course
of chemotherapy for pharmacokinetic studies.
After completion of study therapy, patients are followed periodically for 3 years.
Allocation: Non-Randomized, Primary Purpose: Treatment
Nicole Tubiana-Mathieu, MD
Centre Hospital Regional Universitaire de Limoges
United States: Federal Government