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

NCT00138060 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2010-07-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Institut de Recherche Clinique sur les Cancers et le Sang

    lead OTHER

Principal Investigators

  • Gilles Freyer, MD · Department of Oncology, CHLS, 69310 Pierre Benite, France

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-11-30
Completion
2008-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00138060 on ClinicalTrials.gov