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

This study is currently recruiting participants.
Verified January 2013 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01234922
First received: November 3, 2010
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
Unspecified Adult Solid Tumor, Protocol Specific
 Drug: lisinopril
Drug: losartan potassium
Other: laboratory biomarker analysis
Drug: benazepril hydrochloride
Drug: ramipril
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Changes in Ang1-7 levels are significantly different among patients after ACE-I/ARB treatment [ Time Frame: 7 days post-baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Ang II, VEGF, PlGF, and ACE levels [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral benazepril hydrochloride once daily on days 1-7.
 Other: laboratory biomarker analysis
Correlative studies
Drug: benazepril hydrochloride
Given orally
Other Names:
  • benazepril HCl
  • CGS14824A
  • Lotensin
Experimental: Arm II
Patients receive oral lisinopril once daily on days 1-7.
 Drug: lisinopril
Given orally
Other Names:
  • Prinivil
  • Zestril
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm III
Patients receive oral ramipril twice daily on days 1-7.
 Other: laboratory biomarker analysis
Correlative studies
Drug: ramipril
Given orally
Other Name: Altace
Experimental: Arm IV
Patients receive oral losartan potassium once daily on days 1-7.
 Drug: losartan potassium
Given orally
Other Name: Cozaar
Other: laboratory biomarker analysis
Correlative studies

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234922

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: William Je Petty     336-713-5440     wpetty@wfubmc.edu    
Principal Investigator: William Je Petty            
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: William Petty Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01234922     History of Changes
Other Study ID Numbers: CCCWFU 98710, NCI-2010-02043, IRB00014933
Study First Received: November 3, 2010
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Benazepril
Lisinopril
Ramipril
Losartan
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 21, 2013