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

July 30, 2018 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I
Patients receive oral benazepril hydrochloride once daily on days 1-7.
Other: laboratory biomarker analysis
Correlative studies
Drug: benazepril hydrochloride
Given orally
Other Names:
  • Lotensin
  • benazepril HCl
  • CGS14824A
EXPERIMENTAL: Arm II
Patients receive oral lisinopril once daily on days 1-7.
Other: laboratory biomarker analysis
Correlative studies
Drug: lisinopril
Given orally
Other Names:
  • Prinivil
  • Zestril
EXPERIMENTAL: Arm III
Patients receive oral ramipril twice daily on days 1-7.
Other: laboratory biomarker analysis
Correlative studies
Drug: ramipril
Given orally
Other Names:
  • Altace
EXPERIMENTAL: Arm IV
Patients receive oral losartan potassium once daily on days 1-7.
Other: laboratory biomarker analysis
Correlative studies
Drug: losartan potassium
Given orally
Other Names:
  • Cozaar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter
Time Frame: 7 days post-baseline
7 days post-baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Ang II, VEGF, PlGF, and ACE Levels
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (ESTIMATE)

November 4, 2010

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00014933 (OTHER: WFUHS IRB)
  • NCI-2010-02043 (OTHER: CTRP)
  • CCCWFU 98710 (OTHER: Wake Forest University Health Sciences)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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