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

Phase 2TerminatedNCT01234922

Wake Forest University Health Sciences6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Unspecified Adult Solid Tumor, Protocol Specific

Interventions

lisinoprilDRUG

Given orally

losartan potassiumDRUG

Given orally

laboratory biomarker analysisOTHER

Correlative studies

benazepril hydrochloride

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter

Time frame: 7 days post-baseline

Secondary Outcomes

Change in Ang II, VEGF, PlGF, and ACE Levels

Time frame: 1 week

Data from ClinicalTrials.gov

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