NCT00588835

Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients

A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.

Detailed description

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.

Conditions

• Tumor

Interventions

Type	Name	Description
DRUG	aprepitant	125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.
DRUG	Dexamethasone and Ondansetron during CE-treatment	Standard anti-emetic regimen during CE treatment

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-01-09
• Last updated: 2020-11-30

Locations

2 sites across 1 country: Netherlands