RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy.
OBJECTIVES: * Determine the efficacy of sorafenib, as measured by prostate-specific antigen response, in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the prostate. Secondary * Determine the objective response rate and duration of response in patients treated with this drug. * Determine the tolerability and toxicity of this drug in these patients. * Determine time to treatment failure and overall survival in patients treated with this drug. * Explore the relationship between measures of ras/raf pathway activation (pERK) and response to treatment in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks after going off study treatment and then periodically for survival. Patients with stable or responding disease, when they go off study treatment, are followed every 3 months until relapse or progression. PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study within 12-18 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
BAY 43-9006 given orally at 400 mg BID in a 28 day cycle
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Prostate-specific antigen response and/or progression
Time frame: 2 years
Objective response and/or progression
Time frame: 2 years
Tolerability and toxicity
Time frame: 2 years
Time to treatment failure and overall patient survival
Time frame: 2 years
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Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada