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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Institut de Recherche Clinique sur les Cancers et le Sang
ClinicalTrials.gov Identifier:
NCT00138060
First received: August 26, 2005
Last updated: July 19, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Drug: irinotecan
Drug: 5 fluorouracil
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut de Recherche Clinique sur les Cancers et le Sang:

Primary Outcome Measures:
  • tumor response rate [ Time Frame: during the treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: during the treatment ] [ Designated as safety issue: No ]
  • pharmacokinetics [ Time Frame: during the first administration ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: June 2005
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138060

Locations
France
Department of Oncology, IPC
Grenoble, France, 38100
Department of Oncology, CHU
Grenoble, France, 38043
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
Pfizer
Investigators
Principal Investigator: Gilles Freyer, MD Department of Oncology, CHLS, 69310 Pierre Benite, France
  More Information

Publications:
Responsible Party: Gilles Freyer, IRCCSang
ClinicalTrials.gov Identifier: NCT00138060     History of Changes
Other Study ID Numbers: COLOGEN
Study First Received: August 26, 2005
Last Updated: July 19, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Irinotecan
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014