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

Phase 4

Terminated

• Conditions: Tumor
• Interventions: Drug: Dexamethasone and Ondansetron during CE-treatment; Drug: aprepitant

• Registration Number: NCT00588835
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2007-12-24
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-09
• Study Start: 2008-03
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• between 18 and 75 years of age
• able and willing to sign informed consent form
• indication for treatment with CE regimen
• subject is expected to receive at least 2 cycles of CE regimen
• able to swallow capsules

Exclusion Criteria

• history of sensitivity/idiosyncrasy to aprepitant or excipients
• condition that might interfere with drug absorption, distribution metabolism or excretion.
• history or current abuse of drugs, alcohol or solvents
• inability to understand the nature and extent of the trial and procedures
• participation in a drug trial within 30 days prior to the first dose
• febrile illness within 3 days before the first dose
• concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
• abnormal liver or renal function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Dexamethasone and Ondansetron during CE-treatment	CE cycle with standard anti-emetic regimen.
A	aprepitant	Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Nausea and emetic episodes are recorded	Day 1,3,5 and 8 of each cycle

Trial Locations

Locations (2)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands