Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients (ACE)
|ClinicalTrials.gov Identifier: NCT00588835|
Recruitment Status : Terminated
First Posted : January 9, 2008
Last Update Posted : March 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|Tumor||Drug: aprepitant Drug: Dexamethasone and Ondansetron during CE-treatment||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).|
|Study Start Date :||March 2008|
|Primary Completion Date :||January 2010|
|Study Completion Date :||January 2010|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00588835
|University Medical Center Groningen|
|Radboud University Nijmegen Medical Centre|
|Principal Investigator:||David M. Burger, PharmD PhD||Radboud University|