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

NCT00138060

Last updated date
Study Location
Department of Oncology, CHU
Grenoble, , 38043, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Iyer L, Das S, Janisch L, Wen M, Ramírez J, Karrison T, Fleming GF, Vokes EE, Schilsky RL, Ratain MJ. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J. 2002;2(1):43-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2010)
71
Original Enrollment  ICMJE
 (submitted: August 26, 2005)
75
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00138060
Other Study ID Numbers  ICMJE COLOGEN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilles Freyer, IRCCSang
Study Sponsor  ICMJE Institut de Recherche Clinique sur les Cancers et le Sang
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Gilles Freyer, MDDepartment of Oncology, CHLS, 69310 Pierre Benite, France
PRS Account Institut de Recherche Clinique sur les Cancers et le Sang
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP