Breast Cancer Clinical Trial
Official title:
Evaluating the Effect of Aprepitant on Cyclophosphamide Pharmacokinetics
RATIONALE: Antiemetic drugs, such as aprepitant, may help lessen or prevent nausea and
vomiting in patients undergoing chemotherapy.
PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works
compared to placebo in preventing nausea and vomiting in patients undergoing chemotherapy
for breast cancer.
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.
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