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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.