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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-02043 | Other Identifier | CTRP | |
| IRB00014933 | Other Identifier | WFUHS IRB | |
| CCCWFU 98710 | Other Identifier | Wake Forest University Health Sciences |
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slow accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive oral benazepril hydrochloride once daily on days 1-7. |
|
| Arm II | Experimental | Patients receive oral lisinopril once daily on days 1-7. |
|
| Arm III | Experimental | Patients receive oral ramipril twice daily on days 1-7. |
|
| Arm IV | Experimental | Patients receive oral losartan potassium once daily on days 1-7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lisinopril | Drug | Given orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter | 7 days post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ang II, VEGF, PlGF, and ACE Levels | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Petty | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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Protocol was closed early due to slow accrual
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I | Patients receive oral benazepril hydrochloride once daily on days 1-7. laboratory biomarker analysis: Correlative studies benazepril hydrochloride: Given orally |
| FG001 | Arm II |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| losartan potassium | Drug | Given orally |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
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| benazepril hydrochloride | Drug | Given orally |
|
|
| ramipril | Drug | Given orally |
|
|
Patients receive oral lisinopril once daily on days 1-7.
lisinopril: Given orally
laboratory biomarker analysis: Correlative studies
| FG002 | Arm III | Patients receive oral ramipril twice daily on days 1-7. laboratory biomarker analysis: Correlative studies ramipril: Given orally |
| FG003 | Arm IV | Patients receive oral losartan potassium once daily on days 1-7. losartan potassium: Given orally laboratory biomarker analysis: Correlative studies |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | Patients receive oral benazepril hydrochloride once daily on days 1-7. laboratory biomarker analysis: Correlative studies benazepril hydrochloride: Given orally |
| BG001 | Arm II | Patients receive oral lisinopril once daily on days 1-7. lisinopril: Given orally laboratory biomarker analysis: Correlative studies |
| BG002 | Arm III | Patients receive oral ramipril twice daily on days 1-7. laboratory biomarker analysis: Correlative studies ramipril: Given orally |
| BG003 | Arm IV | Patients receive oral losartan potassium once daily on days 1-7. losartan potassium: Given orally laboratory biomarker analysis: Correlative studies |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter | Posted | Mean | Standard Deviation | Picogram/milliliter | 7 days post-baseline |
|
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Ang II, VEGF, PlGF, and ACE Levels | Data were not analyzed due to insufficient accrual to the study and lack of statistical power. | Posted | 1 week |
|
Adverse events were collected for 7 days after dosing
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I | Patients receive oral benazepril hydrochloride once daily on days 1-7. laboratory biomarker analysis: Correlative studies benazepril hydrochloride: Given orally | 0 | 1 | 1 | 1 | ||
| EG001 | Arm II | Patients receive oral lisinopril once daily on days 1-7. lisinopril: Given orally laboratory biomarker analysis: Correlative studies | 0 | 1 | 1 | 1 | ||
| EG002 | Arm III | Patients receive oral ramipril twice daily on days 1-7. laboratory biomarker analysis: Correlative studies ramipril: Given orally | 0 | 2 | 1 | 2 | ||
| EG003 | Arm IV | Patients receive oral losartan potassium once daily on days 1-7. losartan potassium: Given orally laboratory biomarker analysis: Correlative studies | 0 | 2 | 2 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Investigations | CTC version 3 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hyperglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain, Chest | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
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| vomitting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William J. Petty, MD | Wake Forest Baptist Health | 336-716-3313 | wpetty@wakehealth.edu |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017706 | Lisinopril |
| D019808 | Losartan |
| C044946 | benazepril |
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
|---|
| Participants |
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