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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hypertension, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in Ang1-7 levels are significantly different among patients after ACE-I/ARB treatment

Outcome Time Frame:

7 days post-baseline

Safety Issue:

No

Principal Investigator

William Petty

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 98710

NCT ID:

NCT01234922

Start Date:

February 2011

Completion Date:

February 2016

Related Keywords:

  • Hypertension
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Hypertension

Name

Location

Wake Forest University Health SciencesWinston-Salem, North Carolina  27157