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

Sponsor:	Radboud University
Collaborator:	Merck
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00588835

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
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:

MedlinePlus related topics: Cancer Lung Cancer Nausea and Vomiting

Drug Information available for: Dexamethasone Cisplatin Etoposide Dexamethasone acetate Doxiproct plus Ondansetron hydrochloride Ondansetron Aprepitant Dexamethasone Sodium Phosphate

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
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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.
B: Active Comparator CE cycle with standard anti-emetic regimen.	Drug: Dexamethasone and Ondansetron during CE-treatment Standard anti-emetic regimen during CE treatment

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

Contacts

Contact: David M. Burger, PharmD PhD

255-7484-68553

d.burger@akf.umcn.nl

Locations

Netherlands
UMCN St. Radboud	Recruiting
Nijmegen, Netherlands, 6500 HB
Principal Investigator: D M Burger, Pharm D, PhD
University Medical Center Groningen	Not yet recruiting
Groningen, Netherlands
Contact: An Reyners
Principal Investigator: An Reyners

Sponsors and Collaborators

Radboud University

Merck

Investigators

Principal Investigator:

David M. Burger, PharmD PhD

Radboud University

More Information

No publications provided

Responsible Party:	Radboud University Nijmegen Medical Centre ( Dr. D. Burger, hospital pharmacist )
Study ID Numbers:	UMCN-AKF 07.02, EudraCTnr 2007-003347-73
Study First Received:	December 24, 2007
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00588835 History of Changes
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:

Dexamethasone
Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Serotonin Antagonists
Therapeutic Uses
Antipruritics
Ondansetron
Dermatologic Agents

Dexamethasone acetate
Aprepitant
Tranquilizing Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Glucocorticoids
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010