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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Patients receive oral benazepril hydrochloride once daily on days 1-7.

Group Type EXPERIMENTAL

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

benazepril hydrochloride

Intervention Type DRUG

Given orally

Arm II

Patients receive oral lisinopril once daily on days 1-7.

Group Type EXPERIMENTAL

lisinopril

Intervention Type DRUG

Given orally

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Arm III

Patients receive oral ramipril twice daily on days 1-7.

Group Type EXPERIMENTAL

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

ramipril

Intervention Type DRUG

Given orally

Arm IV

Patients receive oral losartan potassium once daily on days 1-7.

Group Type EXPERIMENTAL

losartan potassium

Intervention Type DRUG

Given orally

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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lisinopril

Given orally

Intervention Type DRUG

losartan potassium

Given orally

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

benazepril hydrochloride

Given orally

Intervention Type DRUG

ramipril

Given orally

Intervention Type DRUG

Other Intervention Names

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Prinivil Zestril Cozaar benazepril HCl CGS14824A Lotensin Altace

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No