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Angiogenesis Inhibitors and Hypertension: Clinical Aspects
This study is currently recruiting participants.
Verified by Erasmus Medical Center, August 2007
Sponsored by: Erasmus Medical Center
Information provided by: Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT00511511
  Purpose

The aim of the study is to find simple clinical and laboratory parameters to predict the development of hypertension and to elucidate the mechanism of hypertension during treatment with the tyrosine kinase inhibitor Sunitinib.


Condition
Hypertension

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Sunitinib Sunitinib malate Tyrosine
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title: Angiogenesis Inhibitors and Hypertension: Clinical Aspects

Further study details as provided by Erasmus Medical Center:

Estimated Enrollment: 80
Study Start Date: August 2007
Estimated Study Completion Date: September 2009
Detailed Description:

Inhibition of angiogenesis with antibodies against vascular endothelial growth factor (VEGF) and VEGF receptor antagonists has become an established treatment for cancer. An unanticipated side effect of angiogenesis inhibitors is the development of hypertension. The pathogenesis of this hypertension is unknown. Not all patients will develop hypertension. However, it is not known which patient will and which patient will not develop hypertension.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, with either renal cell carcinoma or gastro intestinal stromal tumors (GIST) intended to be treated solely with Sunitinib (single-agent treatment) and who are considered fit enough by their treating physician to receive Sunitinib.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511511

Contacts
Contact: Mariette H. Kappers, MD +31-10-4632196 m.h.w.kappers@erasmusmc.nl
Contact: A. H. van den Meiracker, MD, PhD +31-10-4634220 a.vandenmeiracker@erasmusmc.nl

Locations
Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Mariette H. Kappers, MD     +31-10-4632196     m.h.w.kappers@erasmusmc.nl    
Contact: A. H. van den Meiracker, MD, PhD     +31-10-4634220     a.vandenmeiracker@erasmusmc.nl    
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: A. H. van den Meiracker, MD, PhD Erasmus Medical Center
  More Information

Publications:
Zakarija A, Soff G. Update on angiogenesis inhibitors. Curr Opin Oncol. 2005 Nov;17(6):578-83. Review.
Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42.
Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, Dickler M, Overmoyer BA, Reimann JD, Sing AP, Langmuir V, Rugo HS. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005 Feb 1;23(4):792-9.
Sica DA. Angiogenesis inhibitors and hypertension: an emerging issue. J Clin Oncol. 2006 Mar 20;24(9):1329-31. Epub 2006 Jan 30. No abstract available.
Veronese ML, Mosenkis A, Flaherty KT, Gallagher M, Stevenson JP, Townsend RR, O'Dwyer PJ. Mechanisms of hypertension associated with BAY 43-9006. J Clin Oncol. 2006 Mar 20;24(9):1363-9. Epub 2006 Jan 30.
Deanfield JE, Halcox JP, Rabelink TJ. Endothelial function and dysfunction: testing and clinical relevance. Circulation. 2007 Mar 13;115(10):1285-95. Review. No abstract available.
Kuenen BC, Levi M, Meijers JC, Kakkar AK, van Hinsbergh VW, Kostense PJ, Pinedo HM, Hoekman K. Analysis of coagulation cascade and endothelial cell activation during inhibition of vascular endothelial growth factor/vascular endothelial growth factor receptor pathway in cancer patients. Arterioscler Thromb Vasc Biol. 2002 Sep 1;22(9):1500-5.
Bosnjak JJ, Terata K, Miura H, Sato A, Nicolosi AC, McDonald M, Manthei SA, Saito T, Hatoum OA, Gutterman DD. Mechanism of thrombin-induced vasodilation in human coronary arterioles. Am J Physiol Heart Circ Physiol. 2003 Apr;284(4):H1080-6. Epub 2002 Dec 19.
Touyz RM. Regulation of endothelial nitric oxide synthase by thrombin. Hypertension. 2007 Mar;49(3):429-31. Epub 2007 Jan 8. No abstract available.
Ferrara N, Gerber HP, LeCouter J. The biology of VEGF and its receptors. Nat Med. 2003 Jun;9(6):669-76. Review.
Henry TD, Annex BH, McKendall GR, Azrin MA, Lopez JJ, Giordano FJ, Shah PK, Willerson JT, Benza RL, Berman DS, Gibson CM, Bajamonde A, Rundle AC, Fine J, McCluskey ER; VIVA Investigators. The VIVA trial: Vascular endothelial growth factor in Ischemia for Vascular Angiogenesis. Circulation. 2003 Mar 18;107(10):1359-65.
Hood JD, Meininger CJ, Ziche M, Granger HJ. VEGF upregulates ecNOS message, protein, and NO production in human endothelial cells. Am J Physiol. 1998 Mar;274(3 Pt 2):H1054-8.
Li B, Ogasawara AK, Yang R, Wei W, He GW, Zioncheck TF, Bunting S, de Vos AM, Jin H. KDR (VEGF receptor 2) is the major mediator for the hypotensive effect of VEGF. Hypertension. 2002 Jun;39(6):1095-100.
Broere A, Van Den Meiracker AH, Boomsma F, Derkx FH, Veld AJ, Schalekamp MA. Human renal and systemic hemodynamic, natriuretic, and neurohumoral responses to different doses of L-NAME. Am J Physiol. 1998 Dec;275(6 Pt 2):F870-7.
van der Linde NA, Boomsma F, van den Meiracker AH. Role of nitric oxide in modulating systemic pressor responses to different vasoconstrictors in man. J Hypertens. 2005 May;23(5):1009-15.

Study ID Numbers: MEC-2007-155, EudraCT-number: 2007-002038-13
Study First Received: August 3, 2007
Last Updated: August 3, 2007
ClinicalTrials.gov Identifier: NCT00511511  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
hypertension
angiogenesis inhibitors
tyrosine kinase inhibitor
Sunitinib

Study placed in the following topic categories:
Sunitinib
Vascular Diseases
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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