A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (>)500 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Interferon alpha-2; Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

• metastatic renal cell cancer (clear cell type);

• nephrectomy;

• absence of proteinuria.

Exclusion Criteria:

• prior systemic treatment for metastatic renal cell cancer;

• major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start;

• presence of brain metastases or spinal cord compression;

• ongoing need for full dose anticoagulants;

• uncontrolled hypertension;

• clinically significant cardiovascular disease.