EPO906 Therapy in Patients With Prostate Cancer

Inclusion Criteria:

The following patients may be eligible for this study:

• Patients with any histologically proven prostate cancer with measurable metastatic disease or PSA progression > 20ng/ml after initial hormonal therapy will be eligible
• Patients must be maintained on androgen ablation therapy with a LHRH agonist or have undergone orchiectomy
• Patients in whom bicalutamide or flutamide has been recently withdrawn must demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively, beyond the discontinuation of such agents
• Patients taking PC-SPES must discontinue therapy for a minimum of 4 weeks
• For patients with disease progression defined solely by PSA increase: two consecutive rises in PSA measurement, over a 4-week period (each separated from the previous by 2 weeks) - the last measurement must be at least 50% greater than the nadir PSA achieved after the last therapeutic maneuver
• For patients who discontinued bicalutamide therapy prior to study entry, a third rising PSA measurement is required 2 weeks from the second PSA measurement (i.e. over a 6 week period)
• Must have a life expectancy of greater than three (3) months
• Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be up to 2.5 X institutional upper limit of normal if alkaline phosphatase is less than the upper limit of normal, or alkaline phosphatase may be up to 4 X upper limit of normal if transaminases are less than or equal to the upper limit of normal
• For patients with disease progression defined by measurable disease: changes in measurable size of lymph nodes or parenchymal masses on physical or radiologic examination (bone scan findings are not adequate to assess measurable disease).

Exclusion Criteria:

The following patients are not eligible for the study:

• Patients with symptomatic CNS metastases or leptomeningeal involvement
• Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
• Patients with severe cardiac insufficiency
• Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
• Patients who received palliative radiotherapy to tumors located centrally less than 4 weeks (28 days) prior to planned enrollment date (palliative radiotherapy to isolated peripheral bone metastases is allowed)
• Patients experiencing hormone withdrawal syndrome, or are 28 days post-withdrawal of anti-androgen therapy (42 days for bicalutamide)
• Patients who have had more than one prior chemotherapy regimen for hormone-resistant metastatic disease
• Patients with disease measurable only by bone scan
• Patients who have received corticosteroids within the past 28 days (may be waived with approval from Novartis)
• History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer
• Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry
• Patients with radiation therapy or chemotherapy within the last four weeks
• Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
• HIV+ patients