Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants

July 19, 2010 updated by: Institut de Recherche Clinique sur les Cancers et le Sang

Protocole Evaluant Chez Des Patients Porteurs de Cancers Colorectaux Metastatiques l'Interet Des Determinants Genotypiques Pour l'Optimisation de l'Efficacite et de la Tolerance de la Chimiotherapie Par Irinotecan et 5-fluorouracile

This study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1 (UGT1A1) polymorphisms before the first administration.

The results of this identification determine the chemotherapy type: high-dose irinotecan or not.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

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
      • Grenoble, France, 38043
        • Department of Oncology, CHU
      • Grenoble, France, 38100
        • Department of Oncology, IPC
      • Pierre Benite, France, 69310
        • Department of Gastroenterology, CHLS
      • Pierre Benite, France, 69310
        • Department of Oncology - CHLS
      • Saint-Priest-en-Jarez, France, 42271
        • Department of Oncology, ICL
      • Toulouse, France
        • Institut Claudius Regaud

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Has provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice
  • Ages between 18 and 85 years
  • Histologically confirmed colorectal cancer
  • No treatment for metastatic disease
  • No irinotecan previously administered
  • World Health Organization (WHO) performance status < 3

  • Laboratory values :

    • neutrophils > 1.5 x 10^9/L;
    • platelet count > 100 x 10^9/L;
    • serum creatinine < 130µmol/L;
    • serum bilirubin < 2 x upper limit of normal (ULN);
    • ASAT and ALAT < 2.5 x ULN;
    • alkaline phosphatase < 5 x ULN.
  • At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Exclusion Criteria:

  • History of another malignancy except cured basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix, breast or bladder.
  • Other concomitant anticancer therapy.
  • Pregnant or lactating women.
  • Women of childbearing potential unless using a reliable and appropriate contraceptive method.
  • Symptomatic cerebral or leptospiral metastasis.
  • Intestinal obstruction.
  • Uncontrolled seizures (diabetes, severe infection).
  • Clinically significant cardiac disease.
  • Central nervous system disorders or severe psychiatric disability.
  • Participation in any investigational study within 4 weeks.

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
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
tumor response rate
Time Frame: during the treatment
during the treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
toxicity
Time Frame: during the treatment
during the treatment
pharmacokinetics
Time Frame: during the first administration
during the first administration

Collaborators and Investigators

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

Sponsor

Institut de Recherche Clinique sur les Cancers et le Sang

Collaborators

Pfizer

Investigators

  • Principal Investigator: Gilles Freyer, MD, Department of Oncology, CHLS, 69310 Pierre Benite, France

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

June 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

July 20, 2010

Last Update Submitted That Met QC Criteria

July 19, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLOGEN

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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