Status:
COMPLETED
Effect of Aprepitant on Cyclophosphamide Pharmacokinetics in Patients With Breast Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Nausea and Vomiting
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
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 ...
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 * ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00719173
Start Date
August 1 2005
End Date
October 1 2010
Last Update
November 4 2024
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295