Status:
COMPLETED
Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer
Lead Sponsor:
NCIC Clinical Trials Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE2
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 patient...
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. Seco...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 10 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00093457
Start Date
August 10 2004
End Date
January 18 2011
Last Update
August 4 2023
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
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