Back to resultsPilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension
Primary Purpose
Treatment Induced Hypertension
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Minoxidil
Hydralazine
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Induced Hypertension
Eligibility 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.
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Minoxidil
Hydralazine
Outcomes
Primary Outcome Measures
Magnitude of Change in Blood Pressure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00607477
Brief Title
Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension
Official Title
A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
Study has been terminated due to poor accrual.
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Induced Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Minoxidil
Arm Title
2
Arm Type
Active Comparator
Arm Description
Hydralazine
Intervention Type
Drug
Intervention Name(s)
Minoxidil
Intervention Description
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
Intervention Name(s)
Hydralazine
Intervention Description
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
Primary Outcome Measure Information:
Title
Magnitude of Change in Blood Pressure
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Maitland, M.D., Ph.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension
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