Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

Phase 4

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00559676
• Lead Sponsor: Centre Hospital Regional Universitaire de Limoges

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Status Verified: 2009-07
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-13
• Last Update Posted: 2011-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oncogenetic parameters
Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects

Secondary Outcome Measures

Name	Time	Method
Correlations between the pharmacogenetic and pharmacokinetic parameters
Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival

Trial Locations

Locations (1)

Centre Hospital Regional Universitaire de Limoges; 🇫🇷 Limoges, France