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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

May 17, 2010
January 8, 2013
June 2010
October 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01125943 on ClinicalTrials.gov Archive Site
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Bevacizumab and Endothelium Dependent Vasodilation
Bevacizumab and Endothelium Dependent Vasodilation

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.

Not Provided
Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
  • Hypertension
  • Cancer
  • Endothelial Dysfunction
  • Drug: Acetylcholine
    Intra-arterial infusion
  • Drug: Nitroprusside
    Intra arterial infusion
  • Drug: Bevacizumab
    Intra arterial infusion
  • Experimental: Acetylcholine
    Intra-arterial infusion of acetylcholine in two increasing dosages during 5 minutes each during the intra-arterial infusion of bevacizumab
    Interventions:
    • Drug: Acetylcholine
    • Drug: Bevacizumab
  • Experimental: Nitroprusside
    Infusion of two increasing dosages of nitroprusside during 5 minutes each during the continuous infusion of bevacizumab
    Interventions:
    • Drug: Nitroprusside
    • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2011
October 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01125943
BVZAch
Not Provided
G. Rongen, Radboud University
Radboud University
Dutch Cancer Society
Not Provided
Radboud University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP