Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients (ACE)
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|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|
|Actual Primary Completion Date :||January 2010|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|