Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension

Not Applicable

Terminated

• Conditions: Treatment Induced Hypertension
• Interventions: Drug: Minoxidil; Drug: Hydralazine

• Registration Number: NCT00607477
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-02-05
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2010-11-22
• Results First Submitted QC: 2011-01-19
• Results First Posted: 2011-02-16
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Minoxidil	Minoxidil
2	Hydralazine	Hydralazine

Primary Outcome Measures

Name	Time	Method
Magnitude of Change in Blood Pressure	21 days

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States