The question is whether aprepitant should be added to CE cycles (cisplatin containing regimen with etoposide) because of a possible interaction between aprepitant and etoposide.This question derives from the fact that both drugs are metabolised…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Health condition
misselijkheid en braken na toedienen cytostatica kuur
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of aprepitant on the pharmacokinetics of etoposide.
Secondary outcome
Efficacy and safety of the addition of aprepitant to an etoposide containing
cisplatin regimen.
Background summary
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. When
used in a 3-day treatment schedule together with dexamethasone and ondansetron,
aprepitant has demonstrated to improve complete response from 47.8 to 67.7%.
The effect of aprepitant remained present after repeated cycles of
chemotherapy. Based on the positive benefit/risk ratio aprepitant was approved
in the Radboud University Nijmegen Medical Centre for use in cisplatin-based
highly emetogenic (cisplatin dose > 50 mg/m2) chemotherapy cycles. Currently
approximately 7 treatment protocol are used in which aprepitant is added to the
anti-emetic regimen of highly emetogenic cisplatin-based protocols.
Study objective
The question is whether aprepitant should be added to CE cycles (cisplatin
containing regimen with etoposide) because of a possible interaction between
aprepitant and etoposide.
This question derives from the fact that both drugs are metabolised through the
same cytochrome P450 3A4 (CYP3A4).
Theoretically adding aprepitant could lead to more etoposide related toxicity
on day 1 and less etoposide efficacy on day 3-4. The two objectives of the
study are to study the pharmacokinetics of etoposide with and without adding
aprepitant to the standard anti-emetic regimen in patients with metastatic lung
carcinoma treated with standard CE regimen and to study the efficacy and safety
of this combination of medication.
Study design
The ACE study consists of 2 cycles of 21 days. Patients who participate are
devided in group A or group B. The subjects in group A receive aprepitant as
well as standard anti-emetics in the first cycle and standard anti-emetics only
in the second cycle. The subjects in group B receive standard anti-emetics in
the first cycle and in the second cycle they receive aprepitant as well as
standard anti-emetics.
Intervention
The anti-emetic treatment starts at day 1 of the chemotherapy. At that day one
capsule aprepitant (Emend®) 125 mg is given. At day 2 and 3 subjects take one
capsule aprepitant 80mg.
Study burden and risks
The side effects of aprepitant can be: burping, constipation, diarhoea,
dizzyness, tiredness, headache, hiccups, indigestion, loss of appetite and
elevation of liver enzymes.
The needles for the extra blood take could cause discomfort or pain.
The burden and risk are equal for both participant groups.
Geert Grooteplein 10
6500 HB Nijmegen
Nederland
Geert Grooteplein 10
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Subject is at least 18 and no older than 75 years of age
Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
Subject has an indication for treatment with CE regimen
Subject is expected to receive at least 2 cycles of CE regimen
Subject is able to swallow capsules
Exclusion criteria
Documented history of sensitivity/idiosyncrasy to aprepitant capsules or exipients
Relevant history or current condition that might interfere with drug absorption
History or current abuse of drugs, alcohol or solvents
Inability to understand the nature and extent of the trial and the procedures required
Participation in a drug trial within 30 days before 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-003347-73-NL |
| CCMO | NL19351.091.07 |