Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)
The purpose of the study is to investigate whether there is an interaction occurs between etoposide and aprepitant in patients with testis carcinoma treated with the standard BEP regimen.
Also to determine how long treatment with aprepitant is necessary in BEP regimen for 5 consecutive days.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)|
- Pharmacokinetic blood samples will be taken at day 2 at pre-dose,
- at 1/2 hour after intake, at 1, 4, 6, 8 and 24 hours (is day 3) after intake of medication.
- Also at day 5 at the same time points blood samples will be taken.
- Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.
|Estimated Study Completion Date:||September 2008|
Aprepitant is a novel, potent and selective nonpeptide neurokinin-1 receptor antagonist that was licensed in 2004 for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy.More recently the indication for use of aprepitant was extended to patients with moderately emetogenic chemotherapy. Based on experience with the use of aprepitant it appears rational to consider aprepitant as part of the anti-emetic regimen for patients treated with BEP. There are, however, no published data available for the use of aprepitant in this situation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429754
|Principal Investigator:||David M. Burger, PharmD PhD||Radboud University (RUNMC)|