Study Combining Imatinib Mesylate (Gleevec) With Sorafenib in Patients With Androgen-independent Prostate Cancer (AIPC)

Inclusion Criteria

• Patients 18 years of age or older.
• Histologically documented diagnosis of Prostate Cancer regardless of Gleason score.
• Androgen-Independent Prostate Cancer
• At least one measurable site of disease
• Patients must have failed one or more lines of systemic chemotherapy, regardless of the chemotherapeutic agent used. There is NO limit to how many lines of chemotherapy a patient can receive
• Patients receiving anti-coagulation treatment with an agent such as heparin may be allowed to participate. Patients on Warfarin are NOT allowed to participate.
• Last chemotherapy exposure 4 weeks prior to study entry
• Prior exposure to Sorafenib is allowed as long as last Sorafenib dose was 3 weeks or more from study entry
• Prior exposure to Gleevec is an EXCLUSION
• Progression after chemotherapy can be demonstrated radiographically (as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria) or biochemically with prostate-specific antigen (PSA) being elevated more than 25% than previous value as long as a repeat PSA confirms progression. (repeat PSA should be done within 3 weeks from the last one). Patients with bone-only disease are considered progressing if there are two more lesions on a new bone scan.
• Performance status 0,1, 2 (ECOG)
• Adequate end organ function, defined as the following:
• total bilirubin 1.0 x 109/L, platelets > 75 x 109/L.
• Men of childbearing potential must agree to employ an effective barrier method of birth control prior to the study entry, throughout the duration of the study and for up to 3 months following discontinuation of study drug.
• Written, voluntary informed consent.
• Patients are allowed the following concurrent therapies:
• Intravenous bisphosphonates if administered for bone metastases
• luteinizing hormone releasing hormone (LHRH) analogues
• Narcotic-type medical interventions to control malignancy-related pain

Exclusion Criteria

• Patient has received any other investigational agents within 21 days of first day of study drug dosing, unless the disease is rapidly progressing.
• Patient is 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Pulmonary hemorrhage/bleeding event > Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 within 4 weeks of first dose of study drug.
• Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
• Serious non-healing wound, ulcer, or bone fracture.
• Use of St. John's Wort or rifampin (rifampicin).
• Any condition that impairs patient's ability to swallow whole pills.
• Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
• Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
• Patient previously received radiotherapy to ³ 25 % of the bone marrow
• Patient had a major surgery within 2 weeks prior to study entry.
• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.