Study of Biomarkers in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

May 13, 2011 updated by: Centre Hospital Regional Universitaire de Limoges

Phase 4 Study to Characterize and Evaluate Markers of Chemoresistance in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • Centre Hospital Regional Universitaire de Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Oncogenetic parameters
Pharmacogenetic and pharmacokinetic predictors of therapeutic response and toxic effects

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospital Regional Universitaire de Limoges

Investigators

  • Study Chair: Nicole Tubiana-Mathieu, MD, Centre Hospital Regional Universitaire de Limoges

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000574159
  • CHUL-BIO-COLON
  • INCA-RECF0356

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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