Oral Estramustine and Oral Vinorelbine in the Treatment of Hormone-Refractory Prostate Cancer

You may be eligible if

• Inclusion:
• Patients must have a histologic diagnosis of adenocarcinoma of the prostate. (No evidence of brain metastasis or untreated spinal cord compression.)
• Patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate at rising PSA (Prostate Specific Antigen) 4 weeks after withdrawal for flutamide and 6 weeks after withdrawal for bicalutamide or nilutamide.
• Patients must have measurable soft tissue disease or evaluable (abnormal bone scan and/or elevated PSA). If PSA is the only evidence of progressive disease it must be greater than or equal to 4ng/mL.
• Adequate bone marrow, renal and liver function
• ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (a measure of general well being on a scale of 0-5 where 0 represents asymptomatic and 5 represents death)
• Must be at least 18 years of age
• Must have a life expectancy of greater than or equal to 12 weeks
• Exclusion:
• Have previously received vinca alkaloid-based cytotoxic chemotherapy or radiation to greater than or equal to 50% of the total bone marrow.
• Evidence of brain metastasis
• Spinal cord compression
• Prior malignancy except for in situ carcinoma, nonmelanoma skin cancer, or adequately treated malignancy that has been inactive for less than 3 years
• Patients with preexisting neuropathy of greater than or equal to grade 2
• Active gastrointestinal disease, or a disorder that alters gastrointestinal motility or absorption