A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

An Open Label Study of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Low-dose Interferon on Progression-free Survival in Patients With Metastatic Clear Cell Renal Cell Carcinoma.

This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• adult patients, >=18 years of age;
• metastatic RCC with majority (>50%) of conventional clear-cell type;
• prior total nephrectomy for primary RCC;
• at least one measurable or non-measurable lesions;
• ECOG performance score of 0 or 2.

Exclusion Criteria:

• prior systemic treatment for metastatic RCC;
• current or previously treated but non-stable CNS metastases or spinal cord compression;
• major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment;
• significant cardiovascular disease within 6 months prior to enrollment.