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

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: NCT00138060
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : July 20, 2010
Information provided by:
Institut de Recherche Clinique sur les Cancers et le Sang

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: irinotecan Drug: 5 fluorouracil Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2005
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: irinotecan
    180 mg/m² or 260 mg/m² in 90 minutes every 15 days
  • Drug: 5 fluorouracil
    400 mg/m² in bolus in day 1 and 2400 mg/m² in 46 hours perfusion

Primary Outcome Measures :
  1. tumor response rate [ Time Frame: during the treatment ]

Secondary Outcome Measures :
  1. toxicity [ Time Frame: during the treatment ]
  2. pharmacokinetics [ Time Frame: during the first administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00138060

Department of Oncology, CHU
Grenoble, France, 38043
Department of Oncology, IPC
Grenoble, France, 38100
Department of Gastroenterology, CHLS
Pierre Benite, France, 69310
Department of Oncology - CHLS
Pierre Benite, France, 69310
Department of Oncology, ICL
Saint-Priest-en-Jarez, France, 42271
Institut Claudius Regaud
Toulouse, France
Sponsors and Collaborators
Institut de Recherche Clinique sur les Cancers et le Sang
Principal Investigator: Gilles Freyer, MD Department of Oncology, CHLS, 69310 Pierre Benite, France

Responsible Party: Gilles Freyer, IRCCSang Identifier: NCT00138060     History of Changes
Other Study ID Numbers: COLOGEN
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: July 20, 2010
Last Verified: July 2010

Keywords provided by Institut de Recherche Clinique sur les Cancers et le Sang:
genotypic profile
metastatic colorectal 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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs