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Keep this study
Lead
Centre Hospital Regional Universitaire de Limoges
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer
