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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Supportive care, Treatment

Active

18 to 75

Other

UMCN-AKF 07.02
EudraCTnr 2007-003347-73, NCT00588835

Trial Description

Summary

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

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Universitair Medisch Centrum St. Radboud - Nijmegen

Merck and Company, Incorporated

David M. Burger, PharmD PhD

Principal Investigator

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

Trial Sites

Netherlands

Nijmegen

Universitair Medisch Centrum St. Radboud - Nijmegen

D M Burger, Pharm D, PhD Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00588835
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.