Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

Centre Hospital Regional Universitaire de Limoges200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Enrollment

200

Conditions

Colorectal Cancer

Interventions

capecitabineDRUG

fluorouracilDRUG

irinotecan hydrochlorideDRUG

leucovorin calciumDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 PATIENT CHARACTERISTICS: * WHO performance status 0-2 * No contraindication to chemotherapy * Not pregnant or nursing * Fertile patients must use effective contraception * No other severe pathology that is likely to worsen during therapy * No dementia or severely impaired mental condition * No geographical or psychological reasons that would preclude treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior therapy for metastatic cancer * Prior adjuvant chemotherapy allowed * Concurrent bevacizumab or other monoclonal antibody therapy allowed

Locations (1)

Centre Hospital Regional Universitaire de Limoges

Limoges, France

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

Data from ClinicalTrials.gov

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