Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma

Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer

The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.

Inclusion Criteria:

• Histologically documented RCC with metastases.
• Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to disease progression or unacceptable treatment-related toxicity

Exclusion Criteria:

• Any prior systemic treatment for Renal Cell Carcinoma [RCC] other than 1 prior cytokine-based treatment regimen. Cytokine-based regimens containing thalidomide or an anti-angiogenesis agent are not allowed.
• Inability to take oral medication