Carcinoma, Renal Cell Clinical Trial
Official title:
An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
Purpose:
The purpose of the correlative studies is to evaluate levels of serum factors of circulating
VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at
baseline and over the course of initial treatment in order to explore relationships with
baseline patient factors, measurable disease response and clinical progression.
Hypothesis soluble markers of angiogenic growth factors and receptors, and circulating
endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or
sorafenib.
It is recognized that the measurable disease RECIST criteria response rate with mTOR inhibition is likely to be low and that the benefit of such therapy will also include effects on disease stabilization. Disease stabilization is difficult to interpret in the phase II setting. Thus, it is desirable to develop biomarkers which will provide additional information on novel treatment effects and how they might relate to disease progression ;
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