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Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
sorafenib tosylate
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Metastatic or recurrent disease No curative standard therapy exists Hormone-refractory disease Evidence of prostate-specific antigen (PSA) progression during androgen ablation therapy, including medical or surgical castration Documented PSA progression after completion of prior peripheral anti-androgens At least a 25% increase (≥ 5 ng/mL) over a reference value PSA with 2 consecutive rising PSAs taken ≥ 1 week apart Castrate level of testosterone ≤ 1.7 nmol/L for patients on medical androgen ablation Patients receiving luteinizing hormone-releasing hormone agonist therapy must continue this treatment during study participation PSA ≥ 10 ng/mL at the time of study entry Primary tumor tissue (paraffin embedded) must be available for immunohistochemistry Minimal symptomatic disease No requirement for morphine or equivalent dose > 30 mg/day to control pain No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No evidence of bleeding diathesis Hepatic Bilirubin normal AST and ALT ≤ 2.5 times upper limit of normal Renal Serum creatinine normal OR Creatinine clearance ≥ 60 mL/min Cardiovascular No myocardial infarction within the past 6 months No congestive heart failure No unstable angina No active cardiomyopathy No unstable ventricular arrhythmia No uncontrolled hypertension Other No serious infection No active peptic ulcer disease No upper gastrointestinal or other condition that would preclude study compliance with oral medication No uncontrolled psychotic disorder No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib or other study agents No other serious illness or medical condition that would preclude study participation No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or other curatively treated solid tumor PRIOR CONCURRENT THERAPY: Biologic therapy Concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other growth factors allowed for the management of adverse events only Chemotherapy No prior chemotherapy No other prior cytotoxic chemotherapy Endocrine therapy See Disease Characteristics Concurrent steroids allowed provided there has been no increase in steroid requirements within the past 4 weeks AND no increase in dose is planned Radiotherapy At least 4 weeks since prior external-beam radiotherapy except low-dose non-myelosuppressive radiotherapy Concurrent low-dose non-myelosuppressive palliative radiotherapy allowed Surgery Not specified Other No prior investigational anticancer agents No concurrent therapeutic anticoagulation Concurrent prophylactic low-dose warfarin for venous or arterial access devices allowed No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent anticancer therapy No other concurrent investigational therapy No concurrent grapefruit juice Concurrent bisphosphonates allowed

Sites / Locations

  • Tom Baker Cancer Centre - Calgary
  • British Columbia Cancer Agency - Centre for the Southern Interior
  • British Columbia Cancer Agency - Vancouver Cancer Centre
  • CancerCare Manitoba
  • Margaret and Charles Juravinski Cancer Centre
  • London Regional Cancer Program at London Health Sciences Centre
  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Prostate-specific antigen response and/or progression

Secondary Outcome Measures

Objective response and/or progression
Tolerability and toxicity
Time to treatment failure and overall patient survival

Full Information

First Posted
October 6, 2004
Last Updated
August 3, 2023
Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00093457
Brief Title
Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer
Official Title
A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 10, 2004 (Actual)
Primary Completion Date
September 28, 2006 (Actual)
Study Completion Date
January 18, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Intervention Description
BAY 43-9006 given orally at 400 mg BID in a 28 day cycle
Primary Outcome Measure Information:
Title
Prostate-specific antigen response and/or progression
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective response and/or progression
Time Frame
2 years
Title
Tolerability and toxicity
Time Frame
2 years
Title
Time to treatment failure and overall patient survival
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Metastatic or recurrent disease No curative standard therapy exists Hormone-refractory disease Evidence of prostate-specific antigen (PSA) progression during androgen ablation therapy, including medical or surgical castration Documented PSA progression after completion of prior peripheral anti-androgens At least a 25% increase (≥ 5 ng/mL) over a reference value PSA with 2 consecutive rising PSAs taken ≥ 1 week apart Castrate level of testosterone ≤ 1.7 nmol/L for patients on medical androgen ablation Patients receiving luteinizing hormone-releasing hormone agonist therapy must continue this treatment during study participation PSA ≥ 10 ng/mL at the time of study entry Primary tumor tissue (paraffin embedded) must be available for immunohistochemistry Minimal symptomatic disease No requirement for morphine or equivalent dose > 30 mg/day to control pain No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No evidence of bleeding diathesis Hepatic Bilirubin normal AST and ALT ≤ 2.5 times upper limit of normal Renal Serum creatinine normal OR Creatinine clearance ≥ 60 mL/min Cardiovascular No myocardial infarction within the past 6 months No congestive heart failure No unstable angina No active cardiomyopathy No unstable ventricular arrhythmia No uncontrolled hypertension Other No serious infection No active peptic ulcer disease No upper gastrointestinal or other condition that would preclude study compliance with oral medication No uncontrolled psychotic disorder No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib or other study agents No other serious illness or medical condition that would preclude study participation No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or other curatively treated solid tumor PRIOR CONCURRENT THERAPY: Biologic therapy Concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other growth factors allowed for the management of adverse events only Chemotherapy No prior chemotherapy No other prior cytotoxic chemotherapy Endocrine therapy See Disease Characteristics Concurrent steroids allowed provided there has been no increase in steroid requirements within the past 4 weeks AND no increase in dose is planned Radiotherapy At least 4 weeks since prior external-beam radiotherapy except low-dose non-myelosuppressive radiotherapy Concurrent low-dose non-myelosuppressive palliative radiotherapy allowed Surgery Not specified Other No prior investigational anticancer agents No concurrent therapeutic anticoagulation Concurrent prophylactic low-dose warfarin for venous or arterial access devices allowed No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent anticancer therapy No other concurrent investigational therapy No concurrent grapefruit juice Concurrent bisphosphonates allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim N. Chi, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Centre - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
British Columbia Cancer Agency - Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18056648
Citation
Chi KN, Ellard SL, Hotte SJ, Czaykowski P, Moore M, Ruether JD, Schell AJ, Taylor S, Hansen C, Gauthier I, Walsh W, Seymour L. A phase II study of sorafenib in patients with chemo-naive castration-resistant prostate cancer. Ann Oncol. 2008 Apr;19(4):746-51. doi: 10.1093/annonc/mdm554. Epub 2007 Dec 3.
Results Reference
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Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

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