Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer

Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma

The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.

Inclusion Criteria:

• Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer.
• The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given.
• Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function

Exclusion Criteria:

• Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen;
• Prior surgical resection of or irradiation to the only site of measurable disease;
• Ongoing severe hematuria;
• Other active second malignancy;
• Cardiovascular diseases or conditions within the last 12 months;
• Known brain metastases;
• Known HIV-positive or AIDS-related illness;
• Pregnant or breast-feeding women;
• Current participation in other clinical trials;
• Other severe acute or chronic medical conditions.