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

Study Overview
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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.

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.

Official Title
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A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension

Conditions
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Hypertension, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: lisinopril
* Drug: losartan potassium
* Other: laboratory biomarker analysis
* Drug: benazepril hydrochloride
* Drug: ramipril


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral benazepril hydrochloride once daily on days 1-7. | Other: laboratory biomarker analysis<br>* Correlative studies<br>Drug: benazepril hydrochloride<br>* Given orally<br>* Other names: Lotensin;|
| Experimental: Arm II<br>Patients receive oral lisinopril once daily on days 1-7. | Drug: lisinopril<br>* Given orally<br>* Other names: Zestril;Other: laboratory biomarker analysis<br>* Correlative studies<br>|
| Experimental: Arm III<br>Patients receive oral ramipril twice daily on days 1-7. | Other: laboratory biomarker analysis<br>* Correlative studies<br>Drug: ramipril<br>* Given orally<br>* Other names: Altace;|
| Experimental: Arm IV<br>Patients receive oral losartan potassium once daily on days 1-7. | Drug: losartan potassium<br>* Given orally<br>* Other names: Cozaar;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter |  | 7 days post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ang II, VEGF, PlGF, and ACE Levels |  | 1 week |