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

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
irinotecan
5 fluorouracil
Sponsored by
Institut de Recherche Clinique sur les Cancers et le Sang
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring genotypic profile, metastatic colorectal cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Oncology, CHU
  • Department of Oncology, IPC
  • Department of Gastroenterology, CHLS
  • Department of Oncology - CHLS
  • Department of Oncology, ICL
  • Institut Claudius Regaud

Outcomes

Primary Outcome Measures

tumor response rate

Secondary Outcome Measures

toxicity
pharmacokinetics

Full Information

First Posted
August 26, 2005
Last Updated
July 19, 2010
Sponsor
Institut de Recherche Clinique sur les Cancers et le Sang
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00138060
Brief Title
Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut de Recherche Clinique sur les Cancers et le Sang
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
genotypic profile, metastatic colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan
Intervention Description
180 mg/m² or 260 mg/m² in 90 minutes every 15 days
Intervention Type
Drug
Intervention Name(s)
5 fluorouracil
Intervention Description
400 mg/m² in bolus in day 1 and 2400 mg/m² in 46 hours perfusion
Primary Outcome Measure Information:
Title
tumor response rate
Time Frame
during the treatment
Secondary Outcome Measure Information:
Title
toxicity
Time Frame
during the treatment
Title
pharmacokinetics
Time Frame
during the first administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Freyer, MD
Organizational Affiliation
Department of Oncology, CHLS, 69310 Pierre Benite, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, CHU
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Department of Oncology, IPC
City
Grenoble
ZIP/Postal Code
38100
Country
France
Facility Name
Department of Gastroenterology, CHLS
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Department of Oncology - CHLS
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Department of Oncology, ICL
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11990381
Citation
Iyer L, Das S, Janisch L, Wen M, Ramirez 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. doi: 10.1038/sj.tpj.6500072.
Results Reference
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Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants

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