Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer
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.
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With Metastatic Colorectal Cancer|
- Oncogenetic parameters [ Designated as safety issue: No ]
- Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects [ Designated as safety issue: Yes ]
- Correlations between the pharmacogenetic and pharmacokinetic parameters [ Designated as safety issue: No ]
- Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559676
|Centre Hospital Regional Universitaire de Limoges|
|Limoges, France, 87042|
|Study Chair:||Nicole Tubiana-Mathieu, MD||Centre Hospital Regional Universitaire de Limoges|