Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer

NCT ID: NCT00895414

Last Updated: 2019-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2015-10-31

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. 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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Doxorubicin alone first, then Doxorubicin with Enalapril

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.

Group Type: EXPERIMENTAL

doxorubicin hydrochloride

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Doxorubicin with Enalapril first, then Doxorubicin alone

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.

Group Type: EXPERIMENTAL

doxorubicin hydrochloride

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

doxorubicin hydrochloride

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.

Intervention Type: DRUG

enalapril maleate

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.

Intervention Type: DRUG

Other Intervention Names

Adriamycin; Vasotec

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne H. Blaes, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Fairview Southdale Hospital

Edina, Minnesota, United States

University of Minnesota Children's Hospital - Fairview

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0806M34981

Identifier Type: OTHER

Identifier Source: secondary_id

2008NTLS060

Identifier Type: -

Identifier Source: org_study_id