Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
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Determine the objective response rate and duration of response in patients treated with this drug.
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Determine the tolerability and toxicity of this drug in these patients.
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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 Design
Outcome Measures
Primary Outcome Measures
- Prostate-specific antigen response and/or progression [2 years]
Secondary Outcome Measures
- Objective response and/or progression [2 years]
- Tolerability and toxicity [2 years]
- Time to treatment failure and overall patient survival [2 years]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed adenocarcinoma of the prostate
-
Metastatic or recurrent disease
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No curative standard therapy exists
-
Hormone-refractory disease
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Evidence of prostate-specific antigen (PSA) progression during androgen ablation therapy, including medical or surgical castration
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Documented PSA progression after completion of prior peripheral anti-androgens
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At least a 25% increase (≥ 5 ng/mL) over a reference value PSA with 2 consecutive rising PSAs taken ≥ 1 week apart
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Castrate level of testosterone ≤ 1.7 nmol/L for patients on medical androgen ablation
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Patients receiving luteinizing hormone-releasing hormone agonist therapy must continue this treatment during study participation
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PSA ≥ 10 ng/mL at the time of study entry
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Primary tumor tissue (paraffin embedded) must be available for immunohistochemistry
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Minimal symptomatic disease
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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
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Platelet count ≥ 100,000/mm^3
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No evidence of bleeding diathesis
Hepatic
-
Bilirubin normal
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AST and ALT ≤ 2.5 times upper limit of normal
Renal
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Serum creatinine normal OR
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Creatinine clearance ≥ 60 mL/min
Cardiovascular
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No myocardial infarction within the past 6 months
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No congestive heart failure
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No unstable angina
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No active cardiomyopathy
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No unstable ventricular arrhythmia
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No uncontrolled hypertension
Other
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No serious infection
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No active peptic ulcer disease
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No upper gastrointestinal or other condition that would preclude study compliance with oral medication
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No uncontrolled psychotic disorder
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No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib or other study agents
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No other serious illness or medical condition that would preclude study participation
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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
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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
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Concurrent low-dose non-myelosuppressive palliative radiotherapy allowed
Surgery
- Not specified
Other
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No prior investigational anticancer agents
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No concurrent therapeutic anticoagulation
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Concurrent prophylactic low-dose warfarin for venous or arterial access devices allowed
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No concurrent combination antiretroviral therapy for HIV-positive patients
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No other concurrent anticancer therapy
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No other concurrent investigational therapy
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No concurrent grapefruit juice
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Concurrent bisphosphonates allowed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tom Baker Cancer Centre - Calgary | Calgary | Alberta | Canada | T2N 4N2 |
| 2 | British Columbia Cancer Agency - Centre for the Southern Interior | Kelowna | British Columbia | Canada | V1Y 5L3 |
| 3 | British Columbia Cancer Agency - Vancouver Cancer Centre | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 4 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 5 | Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
| 6 | London Regional Cancer Program at London Health Sciences Centre | London | Ontario | Canada | N6A 4L6 |
| 7 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
Sponsors and Collaborators
- NCIC Clinical Trials Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Kim N. Chi, MD, British Columbia Cancer Agency
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I167
- CAN-NCIC-IND167
- CDR0000387987