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 on January 22, 2008. Last Updated on January 19, 2011 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 vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.

Condition	Intervention
Treatment Induced Hypertension	Drug: Minoxidil Drug: Hydralazine

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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
Active Comparator: 1 Minoxidil	Drug: 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
Active Comparator: 2 Hydralazine	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

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 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.

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:	Michael Maitland, MD, PhD, University of Chicago
ClinicalTrials.gov Identifier:	NCT00607477 History of Changes
Other Study ID Numbers:	UCIRB 15386B
Study First Received:	January 22, 2008
Results First Received:	November 22, 2010
Last Updated:	January 19, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydralazine
Minoxidil

Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

ClinicalTrials.gov processed this record on February 12, 2012