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
Sponsored by: Comprehensive Cancer Center of Wake Forest University
Official(s) and/or principal investigator(s):
William Petty, Principal Investigator, Affiliation: Wake Forest University
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
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
I. To determine which drug has the greatest effect on Ang-(1-7) levels in cancer patients
I. To determine the effect of these drugs on levels of Ang II, VEGF, PlGF, and ACE in the
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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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: firstname.lastname@example.org
William Je Petty, Principal Investigator
Starting date: February 2011
Last updated: January 31, 2013