Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Centre Hospital Regional Universitaire de Limoges
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Oncogenetic parameters
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Oncogenetic parameters
Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects
Secondary Outcomes
- Correlations between the pharmacogenetic and pharmacokinetic parameters
- Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival