Carcinoma, Renal Cell Clinical Trial
Official title:
A Single Arm Multicentre Study Evaluating Pazopanib in First-line Treatment of Poor-risk Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
Patients with advanced renal cell carcinoma (RCC) are classified according to Memorial
Sloan-Kettering Cancer Center (MSKCC) criteria in three risk-groups: favourable, intermediate
and poor. To our knowledge there is only one study which examined the poor risk group (Hudes
et al.), which led to the approval of temsirolimus in this population. However temsirolimus
demonstrated a low response rate of 8.6% according to Response Evaluation Criteria In Solid
Tumor (RECIST) criteria and a Progression free Survival (PFS) of 5.5 months and not all
patients are suitable for temsirolimus treatment.
Thus, in clinical routine high-risk patients are also treated with multi Tyrosinkinase
Inhibitors (mTKI). To date, a prospective data acquisition and control of effectiveness of a
mTKI-treatment in high-risk patients has not been conducted.
Pazopanib was recently approved for the first-line treatment of advanced renal cell carcinoma
in Europe and the USA. In the pivotal Phase III trial only nine patients in the pazopanib
group were poor risk according to MSKCC risk criteria and no analysis of this subgroup was
performed. Therefore further data in this group of patients with high medical need is needed.
Currently there are no well-established predictive or prognostic biomarkers in RCC-mTKI
treatment. This is one of the most important scientific questions in this field. In addition
to the clinical endpoints in this study, the comprehensive biomarker program seeks to
evaluate biomarker candidates and will help to learn more about the effects of pazopanib on
the human organism.
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