Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: fluorouracil
* Drug: irinotecan hydrochloride
* Drug: leucovorin calcium
* Drug: oxaliplatin
* Other: laboratory biomarker analysis
* Other: pharmacological study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|nan|
|Drug: fluorouracil|nan|
|Drug: irinotecan hydrochloride|nan|
|Drug: leucovorin calcium|nan|
|Drug: oxaliplatin|nan|
|Other: laboratory biomarker analysis|nan|
|Other: pharmacological study|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncogenetic parameters |  |  | 
| Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations between the pharmacogenetic and pharmacokinetic parameters |  |  | 
| Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer