Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension

This study has been terminated.

( Study has been terminated due to poor accrual. )

First Received: January 22, 2008 Last Updated: February 12, 2009 History of Changes

Sponsor:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00607477

Purpose

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 VEGF inhibitor treatment induced hypertension.

Condition	Intervention
Treatment Induced Hypertension	Drug: Minoxidil Drug: Hydralazine

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Minoxidil Hydralazine Hydralazine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Time to and magnitude of change in blood pressure [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment:	2
Study Start Date:	January 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Minoxidil	Drug: Minoxidil 2.5mg taken twice daily for 1 week, followed by 5mg taken twice daily for the next week, followed by 10mg twice daily for the next week
2: Active Comparator Hydralazine	Drug: Hydralazine 25mg taken twice daily for 1 week, followed by 50mg taken twice daily for the next week, followed by 100mg twice daily for the next week

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ongoing treatment for malignancy by a U. Chicago oncologist with a VSP inhibitor 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 mm Hg or diastolic blood pressure >120 mm Hg in the four (4) weeks prior to screening.
Use of either minoxidil or hydralazine in the six (6) months prior to screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607477

Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Michael Maitland, M.D.

University of Chicago

More Information

No publications provided

Responsible Party:	University of Chicago ( Michael Maitland, MD, PhD )
Study ID Numbers:	UCIRB 15386B
Study First Received:	January 22, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00607477 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Minoxidil
Hydralazine
Vascular Diseases

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009