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).

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.

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