drugset / Trial / NCT01891123

Explore the Individual Treatment of Docetaxel and Paclitaxel in NSCLC, NPC and BRC by PK-guided Dosing Strategy

NCT01891123

Unknown 300 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

As cytotoxic agents, DTX and PTX have a narrow therapeutic window. BSA dosing leads to great inter-individual PK variability, which is a major contributor for severe toxicity, especially in East-Asian populations. DTX exposures measured by area under plasma concentration-time curve (AUC), PTX exposures measured by the time above a plasma concentration of 0.05 µmol/L (TC\>0.05), are the most biologic effects associated PK parameters for DTX and PTX, respectively, which could positively predict related toxicities such as neutropenia, peripheral neuropathy, etc. So, we conducted a randomized clinical trial to compare the effect on related toxicities and efficacy of PK-guided dosing strategy and BSA dosing strategy.

Timeline

Start
2013-06
Primary completion
2016-06
Completion
2016-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2
Comparator Paclitaxel Small molecule 175 mg/m2