The vascular and metabolic effects of sunitinib in patients with metastatic renal cell carcinoma

Completed

Conditions: elevated blood pressure
Hypertension
10018424
10038364
10057166

Registration Number: NL-OMON34257

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In group A: forearm vasomotor response to increasing doses of intra-arterially<br /><br>administered acetylcholine and nitroglycerine before and after start of<br /><br>treatment with sunitinib.<br /><br>In group B: insulin sensitivity measured by hyperinsulinemic euglycemic clamp<br /><br>before and after start of treatment with sunitinib.<br /><br>In group C: GFR and RPF measured by PAH and inulin clearance before and after<br /><br>start of treatment with sunitinib.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To investigate the effect of sunitinib on body weight and blood pressure<br /><br>2. To investigate the effect of sunitinib on levels of VEGF, soluble VEGFR,<br /><br>renin, aldosteron, endothelin-1 and renal function in relation to blood pressure<br /><br>3. To investigate the effect of sunitinib on levels of glucose, total<br /><br>cholesterol, HDL, LDL, triglycerides, insulin, C-peptide, IGF-I, pro-IGF-II,<br /><br>TSH, FT4, leptin, ghrelin, adiponectin, IL-6, IL-18, TNF-a, IFN-γ.<br /><br>4. To investigate the effect of oral daily sunitinib dosing on insulin<br /><br>requirement in the diabetic subpopulation. </p><br>