Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.

Official Title
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A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine

Conditions
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Treatment Induced Hypertension

Intervention / Treatment
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* Drug: Minoxidil
* Drug: Hydralazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ongoing treatment for malignancy by at the University of Chicago with any agent with recognized, specific inhibition of VEGF, VEGF-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. These agents include but are not limited to: bevacizumab (Avastin™), sorafenib (Nexavar™), sunitinib (Sutent™), axitinib (AG-013736), and AZD 2171. Treatment of hypertension with at least 2 or more anti-hypertensive medications with blood pressure remaining greater than 140/90 mmHg. Stable management of other toxicities from the cancer treatments Expected to continue current cancer treatments for at least 4 weeks 18 years and older Ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures. Exclusion Criteria: Concurrent use of hematopoietic supportive treatment with erythropoietin or congeners. Current uncontrolled toxicities due to the cancer treatments. Patients having known contraindications to hydralazine or minoxidil therapy. Any readings of systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg in the four (4) weeks prior to screening. Use of either minoxidil or hydralazine in the six (6) months prior to screening.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Minoxidil | Drug: Minoxidil<br>* 2.5 mg taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week<br>|
| Active Comparator: 2<br>Hydralazine | Drug: Hydralazine<br>* 25 mg taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnitude of Change in Blood Pressure |  | 21 days |