Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	UMN-2008NTLS060 2008NTLS060, 0806M34981, NCT00895414

Objectives

Primary

1. To determine if doxorubicin hydrochloride exposure is increased or decreased with concurrent treatment with doxorubicin hydrochloride and enalapril maleate in women with breast cancer.

Secondary

1. To evaluate the baseline and serial changes in the levels of b-type natriuretic peptide, cardiac troponins, and urine microalbumin after infusion with doxorubicin hydrochloride.
2. To evaluate the effect of enalapril maleate on the formation of the doxorubicin hydrochloride metabolite, doxorubicinol.
3. To evaluate the effect of doxorubicin hydrochloride on intracellular leukocytes and platelets, in the presence and absence of enalapril maleate.

Entry Criteria

Disease Characteristics:

• Tissue diagnosis of a breast carcinoma
• Planning adjuvant doxorubicin hydrochloride every 2 weeks as part of a chemotherapy regimen

Prior/Concurrent Therapy:

• See Disease Characteristics
• More than 1 week since prior and no concurrent herbal supplements
• No concurrent P450 cytochrome inducers or inhibitors
• No concurrent grapefruit juice
• No concurrent angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker

Patient Characteristics:

• Total bilirubin normal
• AST and ALT normal
• Creatinine clearance > 60 mL/min
• Not pregnant or nursing
• No known allergy to enalapril maleate

Expected Enrollment

Outcomes

Increase or decrease in doxorubicin hydrochloride exposure

Baseline and serial 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
Effect of doxorubicin hydrochloride on intracellular leukocytes and platelets, in the presence and absence of enalapril maleate

Outline

Patients are randomized to 1 of 2 treatment arms.

• Arm I: 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.
• Arm II: 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 1, patients receive oral enalapril maleate once daily until day 8 of course 1.

Blood and urine samples are collected periodically for pharmacokinetic studies by HPLC with fluorescence detection.

Trial Contact Information

Trial Lead Organizations

Masonic Cancer Center at University of Minnesota

Anne Blaes, MD, Principal investigator		Ph: 612-624-0123; 888-226-2376

U.S.A.
Minnesota
	Minneapolis
	University of Minnesota Children's Hospital - Fairview
		Clinical Trials Office - University of Minnesota Children's Hospital - Fairview	Ph:  612-273-3000

Registry Information
Official Title		The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment
Trial Start Date		2009-04-06
Trial Completion Date		2009-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00895414
Date Submitted to PDQ		2009-04-16
Information Last Verified		2009-04-16
NCI Grant/Contract Number		CA77598

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