Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension
Information source: University of Chicago
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Treatment Induced Hypertension
Intervention: Minoxidil (Drug); Hydralazine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
Michael Maitland, M.D., Principal Investigator, Affiliation: University of Chicago
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.
Clinical Details
Official title: A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine
Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Time to and magnitude of change in blood pressure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Rolanda Flynn, Phone: 773-834-4059, Email: rflynn@medicine.bsd.uchicago.edu
Michael Maitland, MD, PhD, Principal Investigator
Additional Information
Starting date: January 2008
Ending date: January 2009
Last updated: August 4, 2008
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