The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment
This study is a drug interaction study designed to study the effects of enalapril on
doxorubicin metabolism. Women with breast cancer for whom at least two cycles every 14 day
doxorubicin is planned will be considered for enrollment. Study participation will be for 2
treatment cycles of doxorubicin or approximately 4 weeks. Patients will receive a 14 day
course of daily enalapril in association with one cycle of doxorubicin and receive no study
agent during the other cycle allowing patients to act as their own control. The sequence of
enalapril dosing will be assigned by randomization at study enrollment. Blood samples for
pharmacokinetics will be drawn before and at 7 time points after each of the two doses of
doxorubicin. For each patient, serum doxorubicin and doxorubicinol concentrations both on
and off of enalapril will be compared.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Increase or decrease in doxorubicin hydrochloride exposure
Doxorubicin plasma concentration (DPC) will be the primary pharmacokinetic (PK) measure of the exposure. Each patient will have PK performed twice - once with enalapril and once without enalapril. An increase of more than 115 ng/ml in DPC will be considered important.
Before and After Receiving Enalapril
No
Anne H. Blaes, MD
Principal Investigator
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
2008NTLS060
NCT00895414
April 2009
December 2012
Name | Location |
---|---|
Fairview Southdale Hospital | Edina, Minnesota 55435 |
University of Minnesota Children's Hospital - Fairview | Minneapolis, Minnesota 55455 |