Target Dosing of Docetaxel Through Pharmacokinetic/Pharmacodynamic Optimisation of the First Chemotherapeutic Cycle
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
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