Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00559676
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : May 16, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

Detailed Description:



  • 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
Allocation: Non-Randomized
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Oncogenetic parameters
  2. Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects

Secondary Outcome Measures :
  1. Correlations between the pharmacogenetic and pharmacokinetic parameters
  2. Predictive value of pharmacogenetic and pharmacokinetic parameters on disease-free and overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  • No prior therapy for metastatic cancer
  • Prior adjuvant chemotherapy allowed
  • Concurrent bevacizumab or other monoclonal antibody therapy allowed

Information from the National Library of Medicine

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 identifier (NCT number): NCT00559676

Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Sponsors and Collaborators
Centre Hospital Regional Universitaire de Limoges
Study Chair: Nicole Tubiana-Mathieu, MD Centre Hospital Regional Universitaire de Limoges Identifier: NCT00559676     History of Changes
Other Study ID Numbers: CDR0000574159
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents