Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
- Conditions
- Kidney Cancer
- Registration Number
- NCT00072046
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 732
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall Survival 5 years
- Secondary Outcome Measures
Name Time Method Time to progression q 3 cycles Toxicity q cycle
Trial Locations
- Locations (491)
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Huntsville Hospital
🇺🇸Huntsville, Alabama, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
🇺🇸Ft. Smith, Arkansas, United States
Arroyo Grande Community Hospital
🇺🇸Arroyo Grande, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Kaiser Permanente - Fremont
🇺🇸Fremont, California, United States
Kaiser Permanente Medical Center - Hayward
🇺🇸Hayward, California, United States
Providence Holy Cross Cancer Center
🇺🇸Mission Hills, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Oakland, California, United States
Scroll for more (481 remaining)Comprehensive Cancer Center at University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States