Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

Sponsor

Centre Hospital Regional Universitaire de Limoges (Other)

Overall Status

Completed

CT.gov ID

NCT00559676

Collaborator

(none)

200

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: capecitabine Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin Other: laboratory biomarker analysis Other: pharmacological study	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

Oncogenetic parameters []
Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects []

Secondary Outcome Measures

Correlations between the pharmacogenetic and pharmacokinetic parameters []
Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed metastatic colorectal cancer
Unresectable metastatic disease must be confirmed histologically if > 2 years since primary diagnosis
Measurable metastatic disease > 1 cm by spiral CT scan or > 2 cm by other methods
Scheduled to receive first-line chemotherapy for metastatic disease
Chemotherapy must include fluorouracil, capecitabine, irinotecan hydrochloride, or oxaliplatin
No inadequate or unusable tissue as the only tissue available
No known brain metastases or meningeal disease