Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer|
- Prostate-specific antigen response and/or progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Objective response and/or progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Tolerability and toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Time to treatment failure and overall patient survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
|Study Completion Date:||January 2011|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Drug: sorafenib tosylate
- Determine the efficacy of sorafenib, as measured by prostate-specific antigen response, in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the prostate.
- 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.
|Tom Baker Cancer Centre - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Canada, British Columbia|
|British Columbia Cancer Agency - Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Kim N. Chi, MD||British Columbia Cancer Agency|