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

Primary Purpose

Hypertension, Unspecified Adult Solid Tumor, Protocol Specific

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lisinopril
losartan potassium
laboratory biomarker analysis
benazepril hydrochloride
ramipril
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm IV

Arm Description

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

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

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

Patients receive oral losartan potassium once daily on days 1-7.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 3, 2010
Last Updated
July 30, 2018
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01234922
Brief Title
Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors
Official Title
A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Unspecified Adult Solid Tumor, Protocol Specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral benazepril hydrochloride once daily on days 1-7.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive oral lisinopril once daily on days 1-7.
Arm Title
Arm III
Arm Type
Experimental
Arm Description
Patients receive oral ramipril twice daily on days 1-7.
Arm Title
Arm IV
Arm Type
Experimental
Arm Description
Patients receive oral losartan potassium once daily on days 1-7.
Intervention Type
Drug
Intervention Name(s)
lisinopril
Other Intervention Name(s)
Prinivil, Zestril
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
losartan potassium
Other Intervention Name(s)
Cozaar
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
benazepril hydrochloride
Other Intervention Name(s)
benazepril HCl, CGS14824A, Lotensin
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
ramipril
Other Intervention Name(s)
Altace
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter
Time Frame
7 days post-baseline
Secondary Outcome Measure Information:
Title
Change in Ang II, VEGF, PlGF, and ACE Levels
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Petty
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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