Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors



Status:Terminated
Conditions:Cancer, High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:8/30/2018
Start Date:February 2011
End Date:April 2014

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A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension

RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help
lower blood pressure.

PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril,
ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.

PRIMARY OBJECTIVES:

I. To determine which drug has the greatest effect on Ang-(1-7) levels in cancer patients
with hypertension.

SECONDARY OBJECTIVES:

I. To determine the effect of these drugs on levels of Ang II, VEGF, PlGF, and ACE in the
same patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

- ARM I: Patients receive oral benazepril hydrochloride once daily on days 1-7.

- ARM II: Patients receive oral lisinopril once daily on days 1-7.

- ARM III: Patients receive oral ramipril twice daily on days 1-7.

- ARM IV: Patients receive oral losartan potassium once daily on days 1-7. In all arms,
treatment continues in the absence of unacceptable toxicity.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed solid tumor malignancy
AND hypertension, defined as a systolic pressure > 130 OR a diastolic pressure > 80

- Patients cannot be on active chemotherapy or radiation therapy; start of treatment
with ACE-I or ARB must occur at least four weeks after the last dose of chemotherapy
or radiation therapy

- Creatinine < 2.5

- Potassium < ULN

- Ability to understand and the willingness to sign a written informed consent document

- HIV positive patients are eligible to participate in this study

Exclusion Criteria:

- Patients who are pregnant or nursing due to significant risk to the fetus/infant

- Patients who are unable to take oral medications

- Patients who are currently taking an ACE-Inhibitor or ARB
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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