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Evaluating the Effect of Aprepitant on Cyclophosphamide Pharmacokinetics


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Nausea and Vomiting

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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 HillChapel Hill, North Carolina  27599-7570