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

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

Detailed Description
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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.

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

Conditions
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Tumor

Intervention / Treatment
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* Drug: aprepitant
* Drug: Dexamethasone and Ondansetron during CE-treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment. | Drug: aprepitant<br>* 125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.<br>* Other names: Emend;|
| Active Comparator: B<br>CE cycle with standard anti-emetic regimen. | Drug: Dexamethasone and Ondansetron during CE-treatment<br>* Standard anti-emetic regimen during CE treatment<br>* Other names: Zofran;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and emetic episodes are recorded |  | Day 1,3,5 and 8 of each cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, nausea and vomiting post chemotherapy