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

Tumor Clinical Trial

— ACE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00588835
• Other study ID #: UMCN-AKF 07.02
• Secondary ID: EudraCTnr 2007-0
• Status: Terminated
• Phase: Phase 4
• Start date: March 2008
• Est. completion date: January 2010

Study information

• Verified date: November 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Tumor

Intervention

Drug:
• aprepitant
125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.
• Dexamethasone and Ondansetron during CE-treatment
Standard anti-emetic regimen during CE treatment

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma concentrations of etoposide will be measured		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	Nausea and emetic episodes are recorded		Day 1,3,5 and 8 of each cycle