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Bevacizumab and Endothelium Dependent Vasodilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01125943
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : January 10, 2013
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
G. Rongen, Radboud University Medical Center

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Hypertension Cancer Endothelial Dysfunction Drug: Acetylcholine Drug: Nitroprusside Drug: Bevacizumab Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Bevacizumab and Endothelium Dependent Vasodilation
Study Start Date : June 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Vasomotor response assessed by venous occlusion strain gauge plethysmography [ Time Frame: 15 minutes ]
    Response to infusion of bevacizumab and/or acetylcholin or nitroprusside


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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125943


Locations
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Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University Medical Center
Dutch Cancer Society
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: G. Rongen, Prof dr. G. Rongen, Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT01125943    
Other Study ID Numbers: BVZAch
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Nitroprusside
Acetylcholine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
 Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents