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.
Renal Cell Carcinoma
|Study Design:||Time Perspective: Prospective|
|Official Title:||The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma|
- Endothelial function [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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 ]
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 ]
GFR and RPF measured by PAH and inulin clearance before and after start of treatment with sunitinib
- 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 ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||November 2010|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227213
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6500HB|