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

Wake Forest University (WFU)

Status and phase: Terminated; Phase 2

Conditions: Hypertension; Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: ramipril; Drug: lisinopril; Other: laboratory biomarker analysis; Drug: losartan potassium; Drug: benazepril hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01234922

CCCWFU 98710 (Other Identifier)

NCI-2010-02043 (Other Identifier)

IRB00014933 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 4 patient groups

Arm I

Experimental group

Description:

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

Treatment:

Drug: benazepril hydrochloride

Other: laboratory biomarker analysis

Arm II

Experimental group

Description:

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

Treatment:

Other: laboratory biomarker analysis

Drug: lisinopril

Arm III

Experimental group

Description:

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

Treatment:

Other: laboratory biomarker analysis

Drug: ramipril

Arm IV

Experimental group

Description:

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

Treatment:

Drug: losartan potassium

Other: laboratory biomarker analysis