Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients
Information source: Radboud University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tumor
Intervention: aprepitant (Drug); Dexamethasone and Ondansetron during CE-treatment (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Radboud University Official(s) and/or principal investigator(s):
David M. Burger, PharmD PhD, Principal Investigator, Affiliation: Radboud University
Overall contact:
David M. Burger, PharmD PhD, Phone: 255-7484-68553, Email: d.burger@akf.umcn.nl
Summary
The purpose of this study is to determine whether aprepitant can be used in the Cisplatin -
Etoposide chemotherapeutic regimen.
Clinical Details
Official title: A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: plasma concentrations of etoposide will be measured
Secondary outcome: Nausea and emetic episodes are recorded
Detailed description:
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
David M. Burger, PharmD PhD, Phone: 255-7484-68553, Email: d.burger@akf.umcn.nl
UMCN St. Radboud, Nijmegen 6500 HB, Netherlands; Recruiting
D M Burger, Pharm D, PhD, Principal Investigator
University Medical Center Groningen, Groningen, Netherlands; Not yet recruiting
An Reyners
An Reyners, Principal Investigator
Additional Information
Starting date: March 2008
Ending date: December 2010
Last updated: July 21, 2009
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