Evaluating the Effect of Aprepitant on Cyclophosphamide Pharmacokinetics
18 Years
N/A
Both
Breast Cancer, Nausea and Vomiting
Trial Information
Evaluating the Effect of Aprepitant on Cyclophosphamide Pharmacokinetics
OBJECTIVES:
Primary
- To evaluate the effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide
pharmacokinetics as measured by plasma AUC in patients with breast cancer.
Secondary
- To evaluate total control of nausea and vomiting, as defined by no vomiting episodes
and no use of rescue medication, 72 hours after courses 1 and 2 of chemotherapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive aprepitant 125 mg orally once daily on day 1 and 80 mg orally
once daily on days 2 and 3. Beginning 1 hour after receiving aprepitant, patients
receive an infusion of cyclophosphamide on day 1. During course 2, patients crossover
and receive treatment (placebo) as in arm II.
- Arm II: Patients receive a placebo 125 mg orally once daily on day 1 and 80 mg orally
once daily on days 2 and 3. Beginning 1 hour after receiving the placebo, patients will
receive an infusion of cyclophosphamide infusion on day 1. During course 2, patients
crossover and receive treatment (aprepitant) as in arm I.
Patients complete a diary documenting nausea and vomiting on days 1, 2, and 3 of both
courses. Patients also complete The Functional Living Index-Emesis (FLIE) questionnaire
documenting compliance, rescue antiemetic therapy, and any adverse effects and record them
in the diary for each course. Information in the patient's diary is obtained by the
coordinator via telephone on day 4 of each course.
Patients undergo blood sample collection periodically for pharmacokinetic studies via high
performance liquid chromatography.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Planning to receive cyclophosphamide 600 mg/m²-1,000 mg/m² IV infusion
- No cyclophosphamide dose change between courses 1 and 2
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 2 months
- ANC ≥ 1,500/μL
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤ 1.5 mg/dL
- AST/ALT ≤ 2 times upper limit of normal
- Not pregnant or nursing
- No contraindication to aprepitant
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent medications that are CYP3A4 substrates, inhibitors, and/or inducers,
with the exception of the dexamethasone contained as part of the standard antiemetic
regimen
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide pharmacokinetics as measured by plasma AUC
Outcome Description:
Cyclophosphamide, 4-OH cyclophosphamide, and DCE PK with and without aprepitant
Outcome Time Frame:
05/2005 to 10/2010
Safety Issue:
No
Principal Investigator
Christine M. Walko, PharmD, BCOP
Investigator Role:
Principal Investigator
Investigator Affiliation:
UNC Lineberger Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
LCCC 0514
NCT ID:
NCT00719173
Start Date:
August 2005
Completion Date:
October 2010
Related Keywords:
- Breast Cancer
- Nausea and Vomiting
- nausea and vomiting
- breast cancer
- Breast Neoplasms
- Nausea
- Vomiting
Name | Location |
|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
