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

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Endothelial Growth Factors; Hydralazine; Minoxidil

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.