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

Sponsor
Institut de Recherche Clinique sur les Cancers et le Sang
Study ID
NCT00138060
Phase
PHASE4
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2005
Status verified
Jul 2010
Primary completion
Nov 30, 2008
Completion
Dec 31, 2008

Study Design

Enrollment
71 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

tumor response rate [ Time Frame: during the treatment ]

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