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

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.

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 Investigator: Radboud University Other

Overall Clinical Trial Officials and Contacts

David M. Burger, PharmD PhD Principal Investigator Radboud University  

Information obtained from ClinicalTrials.gov on February 12, 2012

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)