Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-31 @ 1:57 AM
Study NCT ID:
NCT00093457
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Study Overview
Official Title:
A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: