A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- plasma concentrations of etoposide will be measured
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment.
Intervention: aprepitant (Drug)
B
CE cycle with standard anti-emetic regimen.
Intervention: Dexamethasone and Ondansetron during CE-treatment (Drug)
Outcomes
Primary Outcomes
plasma concentrations of etoposide will be measured
Time Frame: 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 Outcomes
- Nausea and emetic episodes are recorded(Day 1,3,5 and 8 of each cycle)