drugset / Trial / NCT00138060
Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants
Phase 4
Completed
71 enrolled
Institut de Recherche Clinique sur les Cancers et le Sang
Pfizer · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |