Kidney Cancer Clinical Trial
Official title:
A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma (RCC) Refractory to SU11248 or Bevacizumab Therapy
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with
metastatic kidney cancer that has not responded to sunitinib or bevacizumab.
OBJECTIVES:
Primary
- To determine the tumor burden reduction rate in patients with sunitinib malate- or
bevacizumab-refractory, metastatic clear cell renal cell carcinoma treated with
sorafenib tosylate.
Secondary
- To determine the safety of sorafenib tosylate in these patients.
- To record the duration of tumor reduction, time to disease progression, and overall
survival of patients treated with sorafenib tosylate.
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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