Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00093457
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Prostate-specific antigen response and/or progression 2 years
- Secondary Outcome Measures
Name Time Method Time to treatment failure and overall patient survival 2 years Tolerability and toxicity 2 years Objective response and/or progression 2 years
Trial Locations
- Locations (7)
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
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
Margaret and Charles Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
🇨🇦London, Ontario, Canada