Breast Cancer, Nausea and Vomiting
Conditions
Keywords
nausea and vomiting, breast cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGaprepitant
Given orally
DRUGcyclophosphamide
Given IV
OTHERplacebo
Given orally
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide pharmacokinetics as measured by plasma AUC | 05/2005 to 10/2010 | Cyclophosphamide, 4-OH cyclophosphamide, and DCE PK with and without aprepitant |
Countries
United States
Outcome results
None listed