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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).


Phase 4
18 Years
75 Years
Not Enrolling
Both
Tumor

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

plasma concentrations of etoposide will be measured

Outcome 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

Principal Investigator

David M. Burger, PharmD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

UMCN-AKF 07.02

NCT ID:

NCT00588835

Start Date:

March 2008

Completion Date:

January 2010

Related Keywords:

  • Tumor
  • pharmacokinetics
  • nausea and vomiting post chemotherapy

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