A Study of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Prostate Cancer

Inclusion Criteria

• •Patient must have histologically proven adenocarcinoma of the prostate gland.
• •Patient must have evidence of progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases) within 6 weeks prior to participation in the study.
• •Patients must not have an elevated PSA level as the only evidence of disease. While castrated, the patients should have rising PSA on two consecutive measurements at least 1 week apart. The confirmatory PSA must be obtained within 1 week prior to study registration and should be \>10ng/ml.
• •Patients with bone metastases only (i.e., lacking soft-tissue disease) must have a PSA level of \> 10 ng/ml. Patients with soft tissue metastases and /or visceral disease must have either measurable disease or a PSA level of \> 10 ng/ml.
• •Radiological evidence of hydronephrosis will not by itself constitute evidence of metastatic disease.
• •Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (e.g., estrogen therapy, LHRH analog + flutamide, etc.) with evidence of treatment failure.
• •NOTE: Patients who have not undergone bilateral orchiectomy must continue LHRH agonist therapy (e.g., depot leuprolide or goserelin) while receiving this protocol therapy.
• •For patients previously treated with flutamide (Eulexin), nilutamide (Nilandron), or bicalutamide (Casodex): Patients must have discontinued flutamide or nilutamide \< 4 weeks and for bicalutamide 6 weeks prior to registration.
• •Patients should not have prior exposure to anthracyclines or estramustine phosphate.
• •Patients must not have had prior radiotherapy \< 4 weeks prior to this protocol treatment.
• +15 more criteria