NCT00520403

A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.

An Open-label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Standard Therapy on Progression-free Survival in Patients With Metastatic Renal Cell Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	bevacizumab [Avastin]	15mg/kg iv every 3 weeks
DRUG	Interferon alfa-2a	3 MioIU sc escalating to 18 MioIU sc, 3 times weekly
DRUG	Vinblastine	0.1mg/kg iv every 3 weeks

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-08-24
• Last updated: 2014-10-13
• Results posted: 2014-10-13

Locations

16 sites across 1 country: Germany