Conditions: Carcinoma, Renal Cell
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 750
Healthy volunteers: no

Brief summary:
The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Interferon-alfa intervention 2: SU011248
Intervention descriptions: intervention 1: 3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity intervention 2: 50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity

Protocol document: