- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00895414
Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer
The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Children's Hospital - Fairview
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
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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.
Other Names:
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.
Other Names:
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EXPERIMENTAL: 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.
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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.
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Doxorubicin Plasma Concentrations Demonstrating a Significant Increase or Decrease When Doxorubicin Was Given With Enalapril as Compared to When Doxorubicin Was Given Without Enalapril.
Time Frame: Baseline, 0.5, 1.0, 2.0, 4.0, 24.0 and 48.0 hours after infusion of doxorubicin
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Doxorubicin plasma concentration (DPC) is the primary pharmacokinetic (PK) measure of the exposure.
Each patient will have serial PKs performed twice - once with enalapril and once without enalapril.
A mean increase or decrease of more than 115 ng/ml in DPC will be considered significant.
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Baseline, 0.5, 1.0, 2.0, 4.0, 24.0 and 48.0 hours after infusion of doxorubicin
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Participants With a Significant Increase or Decrease in the Baseline Levels of Btype Natriuretic Peptide, Cardiac Troponins, and Urine Microalbumin With or Without Enalapril
Time Frame: Baseline, 4, 24 and 48 hours after infusion of doxorubicin
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Doxorubicin can induce changes in troponin, b-type natriuretic peptide and urine microalbumin.
This analysis will determine whether enalapril prevents any of these changes.
Statistical significance defined as a p < 0.05.
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Baseline, 4, 24 and 48 hours after infusion of doxorubicin
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The Number of Participants With a Significant Increase or Decrease in Doxorubicin Hydrochloride Metabolite Levels With or Without Enalapril
Time Frame: Baseline, 0.5, 1.0, 2.0, 4.0, 24.0 and 48.0 hours after infusion of doxorubicin
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Doxorubicin is metabolized to doxorubicinol.
The effects of enalapril on doxorubicinol will be assessed.
Statistical significance defined as a p < 0.05.
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Baseline, 0.5, 1.0, 2.0, 4.0, 24.0 and 48.0 hours after infusion of doxorubicin
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Protease Inhibitors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Angiotensin-Converting Enzyme Inhibitors
- Doxorubicin
- Liposomal doxorubicin
- Enalaprilat
- Enalapril
Other Study ID Numbers
- 2008NTLS060
- 0806M34981 (OTHER: IRB, University of Minnesota)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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