Influence of Individual Dosage Selection of Irinotecan(CPT-11)Based on UGT1A1 Genotype on Pharmacokinetics and Clinical Outcome in Chinese Patients With Metastatic Colorectal Cancer
Genetic polymorphisms of UGTs result in reduced enzyme activity and increased toxicity.
UGT1A1*28 and UGT1A1*6 are reported to increase CPT-11-related toxicity in Asian patients.
Moreover, the area under concentration curve (AUC) ratio of SN-38G to SN-38 is decreased in
Asian patients having UGT1A1 *28 or UGT1A1*6. This implicated that the current standard dose
of CPT-11 would be overdosing for UGT1A1 *28 or UGT1A1 *6 genotype patients.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Association between UGT1A1 polymorphism and incidence of neutropenia and diarrhea
Incidence and grade of neutropenia and diarrhea are record in the whole treatment duration according to NCI-CTC AE 3.0 version
From first 2 weeks to the whole treatment period, an expected average of 6 months
Yes
Xu jianming, MD
Principal Investigator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
China: Ethics Committee
MCRC-307PLAH-XJM
NCT01523431
March 2012
September 2014
Name | Location |
---|