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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00588835
Recruitment Status : Terminated
First Posted : January 9, 2008
Last Update Posted : March 2, 2010
Merck Sharp & Dohme Corp.
Information provided by:
Radboud University

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

Condition or disease Intervention/treatment Phase
Tumor Drug: aprepitant Drug: Dexamethasone and Ondansetron during CE-treatment Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).
Study Start Date : March 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment.
Drug: aprepitant
125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.
Other Name: Emend
Active Comparator: B
CE cycle with standard anti-emetic regimen.
Drug: Dexamethasone and Ondansetron during CE-treatment
Standard anti-emetic regimen during CE treatment
Other Names:
  • Decadron
  • Zofran

Primary Outcome Measures :
  1. plasma concentrations of etoposide will be measured [ 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 ]

Secondary Outcome Measures :
  1. Nausea and emetic episodes are recorded [ Time Frame: Day 1,3,5 and 8 of each cycle ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00588835

University Medical Center Groningen
Groningen, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Merck Sharp & Dohme Corp.
Principal Investigator: David M. Burger, PharmD PhD Radboud University

Responsible Party: Dr. D. Burger, hospital pharmacist, Radboud University Nijmegen Medical Centre Identifier: NCT00588835     History of Changes
Other Study ID Numbers: UMCN-AKF 07.02
EudraCTnr 2007-003347-73
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: February 2010

Keywords provided by Radboud University:
nausea and vomiting post chemotherapy

Additional relevant MeSH terms:
Dexamethasone acetate
BB 1101
Antineoplastic Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents