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

Information source: Comprehensive Cancer Center of Wake Forest University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: lisinopril (Drug); losartan potassium (Drug); laboratory biomarker analysis (Other); benazepril hydrochloride (Drug); ramipril (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Comprehensive Cancer Center of Wake Forest University

Official(s) and/or principal investigator(s):
William Petty, Principal Investigator, Affiliation: Wake Forest University

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.

Clinical Details

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

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

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

Secondary outcome: Change in Ang II, VEGF, PlGF, and ACE levels

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting
William Je Petty, Phone: 336-713-5440, Email: wpetty@wfubmc.edu
William Je Petty, Principal Investigator
Additional Information

Starting date: February 2011
Last updated: January 31, 2013

Page last updated: February 07, 2013

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