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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: September 2009

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment.
• Active Comparator: B
  • CE cycle with standard anti-emetic regimen.

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Nausea and emetic episodes are recorded
  • Time Frame: Day 1,3,5 and 8 of each cycle
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Radboud University

Overall Clinical Trial Officials and Contacts

David M. Burger, PharmD PhD Principal Investigator Radboud University  

Overall Contact: David M. Burger, PharmD PhD 255-7484-68553 d.burger@akf.umcn.nl

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00588835

Study ID Number: UMCN-AKF 07.02

ClinicalTrials.gov Identifier: NCT00588835

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)