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

NCT00607477 | Terminated Results

• 1 other identifier: 15386B
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Induced Hypertension

Outcome Measures

Primary Outcomes (1)

• Magnitude of Change in Blood Pressure

  21 days

Study Arms (2)

1

ACTIVE COMPARATOR

Minoxidil

Drug: Minoxidil

2

ACTIVE COMPARATOR

Hydralazine

Drug: Hydralazine

Interventions

Minoxidil DRUG

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

1

Hydralazine DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years and older
• Ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Minoxidil; Hydralazine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Phthalazines; Pyridazines

Limitations and Caveats

This study enrolled only 2 subjects and due to poor accrual, enrollment was stopped early. Due to the limited number of subjects available results cannot be assessed.

Results Point of Contact

• Title: Michael Maitland, MD, PhD
• Organization: University of Chicago

mmaitlan@medicine.bsd.uchicago.edu

773-702-4400

Study Officials

• Michael Maitland, M.D., Ph.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 10, 2014
• Results First Posted: February 16, 2011

Record last verified: 2014-06

Locations

US (1)