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

NCT ID: NCT00588835

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tumor

Keywords

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pharmacokinetics nausea and vomiting post chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment.

Group Type EXPERIMENTAL

aprepitant

Intervention Type DRUG

125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.

B

CE cycle with standard anti-emetic regimen.

Group Type ACTIVE_COMPARATOR

Dexamethasone and Ondansetron during CE-treatment

Intervention Type DRUG

Standard anti-emetic regimen during CE treatment

Interventions

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aprepitant

125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.

Intervention Type DRUG

Dexamethasone and Ondansetron during CE-treatment

Standard anti-emetic regimen during CE treatment

Intervention Type DRUG

Other Intervention Names

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Emend Decadron Zofran

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Radboud University Nijmegen Medical Centre

Principal Investigators

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David M. Burger, PharmD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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EudraCTnr 2007-003347-73

Identifier Type: -

Identifier Source: secondary_id

UMCN-AKF 07.02

Identifier Type: -

Identifier Source: org_study_id