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
  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:


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:

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

ClinicalTrials.gov processed this record on July 29, 2014