Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
|Clear Cell Renal Cell Carcinoma Papillary Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage III Renal Cell Cancer Stage IV Renal Cell Cancer||Drug: sorafenib tosylate Biological: recombinant interferon alfa Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer|
- Overall response rate (CR+PR) using RECIST criteria [ Time Frame: Up to 5 years ]CR+PR rate will be calculated with exact 90% confidence intervals.
- Grade 3+ toxicities assessed using NCI CTCAE version 3.0 [ Time Frame: Up to 5 years ]Toxicities will be tabulated by type and grade. Toxicity rates will be calculated with exact 90% confidence intervals.
- Progression-free survival [ Time Frame: Up to 5 years ]Kaplan-Meier curves will be used.
- Overall survival [ Time Frame: Up to 5 years ]Kaplan-Meier curves will be used.
- Duration of response [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented , assessed up to 5 years ]Kaplan-Meier curves will be used.
|Study Start Date:||October 2004|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Experimental: Treatment (sorafenib tosylate and recombinant interferon alfa)
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
Drug: sorafenib tosylate
Other Names:Biological: recombinant interferon alfa
Other Names:Other: laboratory biomarker analysis
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098618
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Daniel George||Duke University|