Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments doxorubicin hydrochloride, enalapril maleate
Sponsor Masonic Cancer Center, University of Minnesota
Start date April 2009
End date April 2014
Trial size 17 participants
Trial identifier NCT00895414, 0806M34981, 2008NTLS060

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive doxorubicin hydrochloride IV over 5-10 minutes on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 week before course 2, patients also receive oral enalapril maleate once daily until day 8 of course 2.
doxorubicin hydrochloride Adriamycin
Given IV 5-10 minutes on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.
enalapril maleate Vasotec
Given orally - Beginning 1 week before course 2, patients also receive oral enalapril maleate once daily until day 8 of course 2. OR Beginning 1 week before course 1, patients receive oral enalapril maleate once daily until day 8 of course 1.
(Experimental)
Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 week before course 1, patients receive oral enalapril maleate once daily until day 8 of course 1.
doxorubicin hydrochloride Adriamycin
Given IV 5-10 minutes on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.
enalapril maleate Vasotec
Given orally - Beginning 1 week before course 2, patients also receive oral enalapril maleate once daily until day 8 of course 2. OR Beginning 1 week before course 1, patients receive oral enalapril maleate once daily until day 8 of course 1.

Primary Outcomes

Measure
Increase or decrease in doxorubicin hydrochloride exposure
time frame: Before and After Receiving Enalapril

Secondary Outcomes

Measure
Change in b-type natriuretic peptide, cardiac troponins, and urine microalbumin after infusion with doxorubicin hydrochloride
time frame: Before and After Treatment with Doxorubicin with and without Enalapril
Effect of enalapril maleate on the formation of the doxorubicin hydrochloride metabolite, doxorubicinol
time frame: Before and After Treatment with Doxorubicin with and without Enalapril

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment
Principal investigator Anne H. Blaes, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota.