NCT00559676

Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Centre Hospital Regional Universitaire de Limoges · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	capecitabine
DRUG	fluorouracil
DRUG	irinotecan hydrochloride
DRUG	leucovorin calcium
DRUG	oxaliplatin
OTHER	laboratory biomarker analysis
OTHER	pharmacological study

Timeline

• Start date: 2005-03-01
• Primary completion: 2011-05-01
• First posted: 2007-11-16
• Last updated: 2011-05-16

Locations

1 site across 1 country: France