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The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 25, 2010
Last Update Posted: October 30, 2015
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.
Dutch Cancer Society
Information provided by (Responsible Party):
G. Rongen, Radboud University

Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has improved the outcome of patients with several types of cancer remarkably. However, their application is hampered by side effects, such as development of hypertension with consequences for renal and cardiac function. Moreover patients treated with angiogenesis inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to change. The treatment with angiogenesis inhibitors, will improve life expectancy of patients with various cancer diagnoses and therefore the clinical relevance of both short term and long lasting adverse events will translate into reduced quality of life. In addition, premature withdrawal of angiogenesis inhibitors due to side effects may result in lower response, shorter duration of response and possibly a shorter survival. Therefore, adequate treatment of above mentioned side effects in patients treated with angiogenesis inhibitors is of relevance for the response rate, the duration of progression free survival and overall survival and for quality of life.

Mechanistic insight in the pathogenesis of these side effects will help optimizing treatment.

Objective: The primary objective of the study is to investigate the effect of sunitinib on endothelial function, insulin sensitivity, renal function and renal blood flow.

Study design: Single-centre non randomized observational study Study population: 30 Patients (>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.

Hypertension Renal Function Insulin Sensitivity Renal Cell Carcinoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Endothelial function [ Time Frame: 2 weeks ]

    Group A:

    Vasomotor response to intra-arterially administered doses of acetylcholine and nitroprusside before and after start sunitinib

  • Insulin sensitivity [ Time Frame: 2 weeks ]

    Group B:

    Insulin sensitivity measured by hyperinsulinemic euglycemic clamp before and after start sunitinib

  • GFR and renal perfusion flow [ Time Frame: 2 weeks ]

    Group C:

    GFR and RPF measured by PAH and inulin clearance before and after start of treatment with sunitinib

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 3 months ]
  • Weight [ Time Frame: 3 months ]
  • Laboratory evaluations [ Time Frame: 12 weeks ]

Biospecimen Retention:   Samples Without DNA

Enrollment: 20
Study Start Date: November 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 patients with metastatic renal cell carcinoma starting treatment with sunitinib

Inclusion Criteria:

  • Subject is able and willing to sign the Informed Consent Form
  • Age 18 years or older
  • WHO performance status 0-2
  • Life expectancy ≥ 12 weeks
  • mRCC patients in which the treatment of choice is sunitinib

Exclusion Criteria:

  • Use of corticosteroids
  • Any evidence of severe or uncontrolled diseases other than renal cell carcinoma eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease.
  • Known risk of the patient transmitting HIV, hepatitis B or C via infected blood
  • Patients being treated with oral anticoagulants if to be included in group A.
  Contacts and Locations
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): NCT01227213

Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Dutch Cancer Society
  More Information

Responsible Party: G. Rongen, Prof. dr. Rongen, Radboud University
ClinicalTrials.gov Identifier: NCT01227213     History of Changes
Other Study ID Numbers: SUMAVA
First Submitted: October 22, 2010
First Posted: October 25, 2010
Last Update Posted: October 30, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Insulin Resistance
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors