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

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01234922
First received: November 3, 2010
Last updated: July 21, 2014
Last verified: July 2014

November 3, 2010
July 21, 2014
February 2011
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01234922 on ClinicalTrials.gov Archive Site
Change in Ang II, VEGF, PlGF, and ACE levels [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Change in Ang II, VEGF, PlGF, and ACE levels [ Time Frame: After completion of study treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors
A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: lisinopril
    Given orally
    Other Names:
    • Prinivil
    • Zestril
  • Drug: losartan potassium
    Given orally
    Other Name: Cozaar
  • Other: laboratory biomarker analysis
    Correlative studies
  • Drug: benazepril hydrochloride
    Given orally
    Other Names:
    • benazepril HCl
    • CGS14824A
    • Lotensin
  • Drug: ramipril
    Given orally
    Other Name: Altace
  • Experimental: Arm I
    Patients receive oral benazepril hydrochloride once daily on days 1-7.
    Interventions:
    • Other: laboratory biomarker analysis
    • Drug: benazepril hydrochloride
  • Experimental: Arm II
    Patients receive oral lisinopril once daily on days 1-7.
    Interventions:
    • Drug: lisinopril
    • Other: laboratory biomarker analysis
  • Experimental: Arm III
    Patients receive oral ramipril twice daily on days 1-7.
    Interventions:
    • Other: laboratory biomarker analysis
    • Drug: ramipril
  • Experimental: Arm IV
    Patients receive oral losartan potassium once daily on days 1-7.
    Interventions:
    • Drug: losartan potassium
    • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
April 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01234922
CCCWFU 98710, NCI-2010-02043, IRB00014933
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
Not Provided
Principal Investigator: William Petty Wake Forest School of Medicine
Comprehensive Cancer Center of Wake Forest University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP