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

This study has been terminated.
Sponsor:
Collaborator:
Merck
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00588835
First received: December 24, 2007
Last updated: March 1, 2010
Last verified: February 2010
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nausea and emetic episodes are recorded [ Time Frame: Day 1,3,5 and 8 of each cycle ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588835

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Merck
Investigators
Principal Investigator: David M. Burger, PharmD PhD Radboud University
  More Information

No publications provided

Responsible Party: Dr. D. Burger, hospital pharmacist, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00588835     History of Changes
Other Study ID Numbers: UMCN-AKF 07.02, EudraCTnr 2007-003347-73
Study First Received: December 24, 2007
Last Updated: March 1, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
pharmacokinetics
nausea and vomiting post chemotherapy

Additional relevant MeSH terms:
Cisplatin
Dexamethasone
Etoposide
Dexamethasone acetate
Ondansetron
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Antipruritics
Dermatologic Agents
Serotonin Antagonists

ClinicalTrials.gov processed this record on May 16, 2013