A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma (RCC) Refractory to SU11248 or Bevacizumab Therapy
- To determine the tumor burden reduction rate in patients with sunitinib malate- or
bevacizumab-refractory, metastatic clear cell renal cell carcinoma treated with
- 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
Tumor Burden Reduction Rate (TBRR)
The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.
at 8 weeks (2cycles of treatment)
Brian I. Rini, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|
|Baylor Sammons Cancer Center||Dallas, Texas 75246|