Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients (ACE)
|Tumor||Drug: aprepitant Drug: Dexamethasone and Ondansetron during CE-treatment||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).|
- plasma concentrations of etoposide will be measured [ Time Frame: 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 ]
- Nausea and emetic episodes are recorded [ Time Frame: Day 1,3,5 and 8 of each cycle ]
|Study Start Date:||March 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment.
125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.
Other Name: Emend
Active Comparator: B
CE cycle with standard anti-emetic regimen.
Drug: Dexamethasone and Ondansetron during CE-treatment
Standard anti-emetic regimen during CE treatment
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588835
|University Medical Center Groningen|
|Radboud University Nijmegen Medical Centre|
|Principal Investigator:||David M. Burger, PharmD PhD||Radboud University|