Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Masonic Cancer Center, University of Minnesota
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Tissue diagnosis of a breast carcinoma
The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen
Have acceptable organ function within 14 days of enrollment defined as:
* liver function: total bilirubin, AST and ALT within normal institutional limits
* kidney function: estimated Creatinine Clearance \> 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (sCr x 72)
At least 18 years old
Patient must have given written informed consent indicating an understanding of the investigational nature of the study
Agrees not to consume grapefruit juice while on the study
You may not be if
Known allergy to enalapril
Taking any known P450 cytochrome inducers or inhibitors
Taking any herbal supplements while on the study or the week prior to receiving doxorubicin
Taking an ace-inhibitor or angiotensin receptor blocker
Pregnant or lactating. Enalapril is Pregnancy Categories C (first trimester) and D (second and third trimesters)
Clareo Health | Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer
