Clear Cell Renal Cell Carcinoma Clinical Trial
Official title:
A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth or by blocking blood flow to the tumor. Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa kill more tumor cells by making tumor cells more sensitive to the drug. Giving sorafenib together with interferon alfa may kill more tumor cells. This phase II trial is studying how well giving sorafenib with interferon alfa works in treating patients with locally advanced or metastatic kidney cancer.
PRIMARY OBJECTIVES:
I. Determine the feasibility and tolerability of sorafenib and interferon alfa in patients
with locally advanced or metastatic renal cell carcinoma.
II. Determine the response rate (complete response and partial response) in patients treated
with this regimen.
SECONDARY OBJECTIVES:
I. Determine the progression-free survival and response duration of patients treated with
this regimen.
II. Correlate changes in laboratory parameters with response in patients treated with this
regimen.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily and interferon alfa subcutaneously three times a
week for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or
unacceptable toxicity.
Patients with stable or responding disease are followed every 3 months for 2 years, every 6
months for 2 years, and then annually for 1 year or until disease progression.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 10 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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