Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: sorafenib tosylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sorafenib tosylate|BAY 43-9006 given orally at 400 mg BID in a 28 day cycle|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate-specific antigen response and/or progression |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response and/or progression |  | 2 years | 
| Tolerability and toxicity |  | 2 years | 
| Time to treatment failure and overall patient survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate