drugset / Trial / NCT00703378
Target Dosing of Docetaxel Through Pharmacokinetic/Pharmacodynamic Optimisation of the First Chemotherapeutic Cycle
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective 1\. To develop a pharmacokinetic-pharmacodynamic (PD) model for optimisation of docetaxel dosing Secondary Objectives 1. To establish an exposure-toxicity (neutropenia) relationship for docetaxel 2. To determine the exposure breakpoint for docetaxel toxicity based on a neutropenia PD model 3. To identify demographic, pathophysiological and/or phenotypic covariates predicting docetaxel clearance 4. To prospectively validate this PK-PD model for optimisation of docetaxel dosage and determination PK variability and toxicity
Timeline
- Start
- 2006-05
- Primary completion
- 2011-02
- Completion
- 2012-02
Publications
- Background Goh BC, Lehnert M, Lim HL, Ng AW, Chan CC, Kong HL, Lee SC, Wee J, Chua ET, Wong JE. Phase II trial of docetaxel in Asian patients with inoperable stage III non-small cell lung cancer. Acta Oncol. 2000;39(2):225-9. doi: 10.1080/028418600430824.
- Background Goh BC, Lee SC, Wang LZ, Fan L, Guo JY, Lamba J, Schuetz E, Lim R, Lim HL, Ong AB, Lee HS. Explaining interindividual variability of docetaxel pharmacokinetics and pharmacodynamics in Asians through phenotyping and genotyping strategies. J Clin Oncol. 2002 Sep 1;20(17):3683-90. doi: 10.1200/JCO.2002.01.025.
- Syn NL, Wang L, Wong AL, Soe MY, Chuah B, Chan D, Tan SH, Soo RA, Lee SC, Goh BC, Yong WP. Dose modifications in Asian cancer patients with hepatic dysfunction receiving weekly docetaxel: A prospective pharmacokinetic and safety study. Cancer Sci. 2016 Feb;107(2):173-80. doi: 10.1111/cas.12856. Epub 2016 Feb 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 20 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 30 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 40 mg/m2 | — |