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

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ClinicalTrials.gov Identifier: NCT01227213
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : October 30, 2015
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
G. Rongen, Radboud University

Brief Summary:

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.


Condition or disease
Hypertension Renal Function Insulin Sensitivity Renal Cell Carcinoma

Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Official Title: The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma
Study Start Date : November 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sunitinib




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

    Group A:

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


  2. Insulin sensitivity [ Time Frame: 2 weeks ]

    Group B:

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


  3. 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 :
  1. Blood pressure [ Time Frame: 3 months ]
  2. Weight [ Time Frame: 3 months ]
  3. Laboratory evaluations [ Time Frame: 12 weeks ]

Biospecimen Retention:   Samples Without DNA
plasma


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Criteria

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.

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


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

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

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