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• •Patients in whom bicalutamide or flutamide has been recently withdrawn must demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively, beyond the discontinuation of such agents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).