Status:
COMPLETED
Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Enala...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00895414
Start Date
April 1 2009
End Date
October 1 2015
Last Update
May 8 2019
Active Locations (2)
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1
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
2
University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, United States, 55455