NCT00072046

Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)

A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 732 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cell carcinoma (kidney cancer). PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma.

Detailed description

OBJECTIVES: Primary * Compare the overall survival of patients with advanced renal cell carcinoma treated with interferon alfa-2b alone or interferon alfa-2b with bevacizumab. Secondary * Compare the time to disease progression and objective response rates in patients treated with these regimens. * Determine the toxicity of interferon alfa-2b in combination with bevacizumab in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior nephrectomy (yes vs no) and number of risk factors for disease progression (0 vs 1-2 vs 3 or more). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive interferon alfa-2b subcutaneously (SC) three times a week. * Arm II: Patients receive interferon alfa-2b as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then annually for up to 10 years after study entry. PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab	10mg/kg IV infusion on Days 1 \& 15 of each cycle
BIOLOGICAL	recombinant interferon alfa	9 million units subQ injection 3 x/week for 4 weeks

Timeline

• Start date: 2003-10-01
• Primary completion: 2004-01-01
• Completion: 2012-11-01
• First posted: 2003-11-06
• Last updated: 2016-07-06

Locations

493 sites across 2 countries: United States, Canada