Effect of Aprepitant on Cyclophosphamide Pharmacokinetics in Patients With Breast Cancer

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aprepitant; Cyclophosphamide; Fosaprepitant

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