Bevacizumab and Endothelium Dependent Vasodilation

This study has been completed.

Sponsor:

Collaborator:

Dutch Cancer Society

Information provided by (Responsible Party):

G. Rongen, Radboud University

ClinicalTrials.gov Identifier:

NCT01125943

First received: May 17, 2010

Last updated: January 8, 2013

Last verified: January 2013

History of Changes

Purpose

The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most reported side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody against vascular endothelial growth factor, hypertension had an overall incidence up to 32%. The increase in blood pressure occurs early in treatment. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this side effect is essential for optimal treatment with this class of drugs.

The primary objective is to explore the effect of bevacizumab infusion on endothelium-dependent vasodilation of forearm resistance arteries.

Condition	Intervention
Hypertension Cancer Endothelial Dysfunction	Drug: Acetylcholine Drug: Nitroprusside Drug: Bevacizumab


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Bevacizumab and Endothelium Dependent Vasodilation

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Acetylcholine chloride Sodium nitroprusside Nitroprusside Bevacizumab

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

Vasomotor response assessed by venous occlusion strain gauge plethysmography [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Response to infusion of bevacizumab and/or acetylcholin or nitroprusside


Enrollment:	24
Study Start Date:	June 2010
Study Completion Date:	November 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Acetylcholine Intra-arterial infusion of acetylcholine in two increasing dosages during 5 minutes each during the intra-arterial infusion of bevacizumab	Drug: Acetylcholine Intra-arterial infusion Drug: Bevacizumab Intra arterial infusion
Experimental: Nitroprusside Infusion of two increasing dosages of nitroprusside during 5 minutes each during the continuous infusion of bevacizumab	Drug: Nitroprusside Intra arterial infusion Drug: Bevacizumab Intra arterial infusion

Eligibility


Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 18-50 years old
Male
Results of serum glucose, lipids and creatinine should be within the laboratory's reference ranges.
Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion Criteria:

Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
History of or current abuse of drugs, alcohol or solvents.
History of malignant disease.
First degree relatives with a history of cancer before the age of 50
First degree relatives with a history of premature cardiovascular disease before the age of 50
Current use of medication.
Clinical evidence of cardiac or pulmonary disease
Hypertension ( systole >140mmHG, diastole >90mmHg)
Diabetes mellitus
Smoking
Any clinically relevant abnormality on ECG.
A history of thrombosis or first degree family members with a history of recurrent thrombosis
Inability to understand the nature and extent of the trial and the procedures required.
Previous participation in a study with bevacizumab

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125943

Locations


Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands

Sponsors and Collaborators

Radboud University

Dutch Cancer Society

More Information

No publications provided


Responsible Party:	G. Rongen, Prof dr. G. Rongen, Radboud University
ClinicalTrials.gov Identifier:	NCT01125943 History of Changes
Other Study ID Numbers:	BVZAch
Study First Received:	May 17, 2010
Last Updated:	January 8, 2013
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:


Acetylcholine Bevacizumab Nitroprusside Angiogenesis Inhibitors Angiogenesis Modulating Agents Antihypertensive Agents Antineoplastic Agents Cardiovascular Agents Cholinergic Agents Cholinergic Agonists	Growth Inhibitors Growth Substances Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Nitric Oxide Donors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Vasodilator Agents

ClinicalTrials.gov processed this record on February 27, 2015

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