drugset / Trial / NCT00138060

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

NCT00138060

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-06
Primary completion
2008-11
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 180 mg/m2
Subject Irinotecan Small molecule 260 mg/m2
Subject fluorouracil Small molecule 400 mg/m2
Subject fluorouracil Small molecule 2400 mg/m2

Indications