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

Tracking Information

First Received Date ^ICMJE

January 22, 2008

Last Updated Date

February 12, 2009

Start Date ^ICMJE

January 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00607477 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Treatment Induced Hypertension

Intervention ^ICMJE

Drug: Minoxidil
Drug: Hydralazine

Study Arms / Comparison Groups

Active Comparator: Minoxidil
Active Comparator: Hydralazine

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00607477

Responsible Party

Michael Maitland, MD, PhD, University of Chicago

Study ID Numbers ^ICMJE

UCIRB 15386B

Study Sponsor ^ICMJE

University of Chicago

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Michael Maitland, M.D.

University of Chicago

Information Provided By

University of Chicago

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP