Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00559676|
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : May 16, 2011
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|
- Research the oncogenetic parameters and pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects.
- 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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Official Title:||Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||May 2011|
- Oncogenetic parameters
- Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects
- Correlations between the pharmacogenetic and pharmacokinetic parameters
- Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559676
|Centre Hospital Regional Universitaire de Limoges|
|Limoges, France, 87042|
|Study Chair:||Nicole Tubiana-Mathieu, MD||Centre Hospital Regional Universitaire de Limoges|