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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


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 hydrochloride

Effect 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- Tissue diagnosis of a breast carcinoma

- The oncologist must have prescribed doxorubicin as part of the planned chemotherapy


- 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


- 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

Page last updated: August 23, 2015

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