Conditions: Renal Cell Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief summary:
This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: bevacizumab [Avastin] intervention 2: Interferon alfa-2a intervention 3: Vinblastine
Intervention descriptions: intervention 1: 15mg/kg iv every 3 weeks intervention 2: 3 MioIU sc escalating to 18 MioIU sc, 3 times weekly intervention 3: 0.1mg/kg iv every 3 weeks

Protocol document: