Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00093457|
Recruitment Status : Completed
First Posted : October 8, 2004
Last Update Posted : April 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: sorafenib tosylate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer|
|Actual Study Start Date :||July 21, 2004|
|Actual Primary Completion Date :||September 28, 2006|
|Actual Study Completion Date :||January 18, 2011|
- Drug: sorafenib tosylate
BAY 43-9006 given orally at 400 mg BID in a 28 day cycle
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093457
|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|