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NCT Number: NCT01227213

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

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.

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Key information

Conditions

Hypertension Adenocarcinoma Carcinoma Carcinoma, Renal Cell Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nutritional and Metabolic Diseases Renal Cell Carcinoma Renal Function Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Blood pressure

    Time frame: 3 months

  2. Weight

    Time frame: 3 months

  3. Laboratory evaluations

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Dutch Cancer Society

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 25, 2010
Registry last updated
Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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