Colorectal Cancer Clinical Trial
Official title:
Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with
cancer receiving chemotherapy may help doctors understand the effect of chemotherapy on
biomarkers. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This phase IV trial is studying biomarkers in patients undergoing chemotherapy for
metastatic colorectal cancer.
OBJECTIVES:
Primary
- Research the oncogenetic parameters and pharmacogenetic and pharmacokinetic predictors
of therapeutic response and toxic effects.
Secondary
- 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
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