Clinical trial NCT01227213: The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma
Official title: The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Renal Function
Insulin Sensitivity
Renal Cell Carcinoma
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2010-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients with metastatic renal cell carcinoma starting treatment with sunitinib

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.


Eligibility 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.

Primary outcomes:
measure: Endothelial function
timeFrame: 2 weeks
measure: Insulin sensitivity
timeFrame: 2 weeks
measure: GFR and renal perfusion flow
timeFrame: 2 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: 3 months
measure: Weight
timeFrame: 3 months
measure: Laboratory evaluations
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
References:
citation: Thijs AM, van Herpen CM, Verweij V, Pertijs J, van den Broek PH, van der Graaf WT, Rongen GA. Impaired endothelium-dependent vasodilation does not initiate the development of sunitinib-associated hypertension. J Hypertens. 2015 Oct;33(10):2075-82. doi: 10.1097/HJH.0000000000000662.
citation: Thijs AM, Tack CJ, van der Graaf WT, Rongen GA, van Herpen CM. The early effect of sunitinib on insulin clearance in patients with metastatic renal cell carcinoma. Br J Clin Pharmacol. 2016 Apr;81(4):768-72. doi: 10.1111/bcp.12797. Epub 2016 Jan 14.