Kidney Cancer Clinical Trial
Official title:
A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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