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Bevacizumab and Endothelium Dependent Vasodilation

This study has been completed.
Dutch Cancer Society
Information provided by (Responsible Party):
G. Rongen, Radboud University Identifier:
First received: May 17, 2010
Last updated: January 8, 2013
Last verified: January 2013

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: None (Open Label)
Official Title: Bevacizumab and Endothelium Dependent Vasodilation

Resource links provided by NLM:

Further study details as provided by G. Rongen, Radboud University:

Primary Outcome Measures:
  • Vasomotor response assessed by venous occlusion strain gauge plethysmography [ Time Frame: 15 minutes ]
    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


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
  2. History of or current abuse of drugs, alcohol or solvents.
  3. History of malignant disease.
  4. First degree relatives with a history of cancer before the age of 50
  5. First degree relatives with a history of premature cardiovascular disease before the age of 50
  6. Current use of medication.
  7. Clinical evidence of cardiac or pulmonary disease
  8. Hypertension ( systole >140mmHG, diastole >90mmHg)
  9. Diabetes mellitus
  10. Smoking
  11. Any clinically relevant abnormality on ECG.
  12. A history of thrombosis or first degree family members with a history of recurrent thrombosis
  13. Inability to understand the nature and extent of the trial and the procedures required.
  14. Previous participation in a study with bevacizumab
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Please refer to this study by its identifier: NCT01125943

Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Dutch Cancer Society
  More Information

Responsible Party: G. Rongen, Prof dr. G. Rongen, Radboud University Identifier: NCT01125943     History of Changes
Other Study ID Numbers: BVZAch
Study First Received: May 17, 2010
Last Updated: January 8, 2013

Additional relevant MeSH terms:
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Vasodilator Agents
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Nitric Oxide Donors processed this record on September 21, 2017