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

Phase 2

Terminated

• Conditions: Hypertension; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Other: laboratory biomarker analysis; Drug: lisinopril; Drug: losartan potassium; Drug: ramipril; Drug: benazepril hydrochloride

• Registration Number: NCT01234922
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Study Start: 2011-02
• Primary Completion: 2013-12
• Study Completion: 2014-04
• Results First Submitted: 2014-12-09
• Results First Submitted QC: 2014-12-09
• Results First Posted: 2014-12-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	laboratory biomarker analysis	Patients receive oral benazepril hydrochloride once daily on days 1-7.
Arm II	lisinopril	Patients receive oral lisinopril once daily on days 1-7.
Arm II	laboratory biomarker analysis	Patients receive oral lisinopril once daily on days 1-7.
Arm III	laboratory biomarker analysis	Patients receive oral ramipril twice daily on days 1-7.
Arm III	ramipril	Patients receive oral ramipril twice daily on days 1-7.
Arm IV	laboratory biomarker analysis	Patients receive oral losartan potassium once daily on days 1-7.
Arm I	benazepril hydrochloride	Patients receive oral benazepril hydrochloride once daily on days 1-7.
Arm IV	losartan potassium	Patients receive oral losartan potassium once daily on days 1-7.

Primary Outcome Measures

Name	Time	Method
Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter	7 days post-baseline

Secondary Outcome Measures

Name	Time	Method
Change in Ang II, VEGF, PlGF, and ACE Levels	1 week

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States