A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).
Aprepitant acts initially as a moderate inhibitor of CYP3A4 followed by a short period of
CYP3A4 induction. Etoposide is a substrate of CYP3A4 and may therefore be suvject to a drug
interaction with aprepitant.
CE can be classified as a highly emetogenic chemotherapeutic regimen and the use of
aprepitant may therefore be considered when no clinically relevant drug interaction with
etoposide can be determined.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
plasma concentrations of etoposide will be measured
just before etoposide infusion, at 0.5, 1,4,6,8 and 24 hours and 32 hours after dosing on study days 1 and 3
David M. Burger, PharmD PhD
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)