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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00588835

Acronym

ACE

Enrollment

Registered

2008-01-09

Start date

2008-03-31

Completion date

2010-01-31

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor

Keywords

pharmacokinetics, nausea and vomiting post chemotherapy

Brief summary

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

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.

Interventions

DRUGaprepitant

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

DRUGDexamethasone and Ondansetron during CE-treatment

Standard anti-emetic regimen during CE treatment

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Nausea and emetic episodes are recorded	Day 1,3,5 and 8 of each cycle

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026