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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-01-31

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.

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Detailed Description

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Conditions

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Treatment Induced Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Minoxidil

Group Type ACTIVE_COMPARATOR

Minoxidil

Intervention Type DRUG

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

2

Hydralazine

Group Type ACTIVE_COMPARATOR

Hydralazine

Intervention Type DRUG

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

Interventions

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Minoxidil

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

Intervention Type DRUG

Hydralazine

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

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No