Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer
Information source: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: doxorubicin hydrochloride (Drug); enalapril maleate (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Masonic Cancer Center, University of Minnesota Official(s) and/or principal investigator(s): Anne H. Blaes, MD, Principal Investigator, Affiliation: Masonic Cancer Center, University of Minnesota
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. Enalapril maleate may help protect heart cells from the side effects of
chemotherapy. It is not yet known whether giving enalapril maleate before or after
doxorubicin hydrochloride is more effective in treating women with breast cancer.
PURPOSE: This randomized clinical trial is studying giving enalapril maleate together with
doxorubicin hydrochloride to see how well it works in treating women with breast cancer.
Clinical Details
Official title: The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Increase or decrease in doxorubicin hydrochloride exposure
Secondary outcome: Change in b-type natriuretic peptide, cardiac troponins, and urine microalbumin after infusion with doxorubicin hydrochlorideEffect of enalapril maleate on the formation of the doxorubicin hydrochloride metabolite, doxorubicinol
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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)
Locations and Contacts
Fairview Southdale Hospital, Edina, Minnesota 55435, United States
University of Minnesota Children's Hospital - Fairview, Minneapolis, Minnesota 55455, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 2009
Last updated: April 23, 2015
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