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

Radboud University Medical Center

Status and phase

Terminated

Phase 4

Conditions

Tumor

Treatments

Drug: Dexamethasone and Ondansetron during CE-treatment

Drug: aprepitant

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00588835

UMCN-AKF 07.02

EudraCTnr 2007-003347-73

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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