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

This study is currently recruiting participants.
Verified January 2013 by Radboud University
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
G. Rongen, Radboud University
ClinicalTrials.gov Identifier:
NCT01227213
First received: October 22, 2010
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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
Hypertension
Renal Function
Insulin Sensitivity
Renal Cell Carcinoma

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Endothelial function [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    Group A:

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


  • Insulin sensitivity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    Group B:

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


  • GFR and renal perfusion flow [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Laboratory evaluations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227213

Contacts
Contact: Annemarie Thijs, MD A.thijs@aig.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6500HB
Contact: A M Thijs, MD    +243613691      
Sub-Investigator: A Thijs, MD         
Sponsors and Collaborators
Radboud University
Dutch Cancer Society
  More Information

No publications provided

Responsible Party: G. Rongen, Prof. dr. Rongen, Radboud University
ClinicalTrials.gov Identifier: NCT01227213     History of Changes
Other Study ID Numbers: SUMAVA
Study First Received: October 22, 2010
Last Updated: January 8, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Hypertension
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
Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014