Clinical trial NCT00028769 (phase 2, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: bicalutamide, estramustine, etoposide, flutamide, goserelin, leuprolide, nilutamide, paclitaxel
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Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate

               -  Clinical stage D2 disease as evidenced by one of the following:

                    -  Visceral disease (liver, lung, or other viscera)

                    -  Bone metastases to sites in both the axial (spine, pelvis, ribs, or skull)
                       and appendicular (claviculae, humeri, or femora) skeleton

          -  No prior or concurrent (treated or untreated) brain metastases

               -  Patients with clinical evidence of brain metastasis must have a negative brain CT
                  or MRI

          -  No evidence of untreated spinal cord compression

        PATIENT CHARACTERISTICS:

        Age:

          -  Over 18

        Performance status:

          -  Zubrod 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  No active hypercoagulability

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        Cardiovascular:

          -  No transient ischemic attacks, stroke, or myocardial infarction within the past 6
             months

          -  No active coronary artery disease requiring antianginal therapy

          -  No active thrombophlebitis

        Pulmonary:

          -  No history of pulmonary embolus

        Other:

          -  No other prior malignancy within the past 5 years except adequately treated basal cell
             or squamous cell skin cancer or adequately treated stage I or II cancer currently in
             complete remission

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 4 weeks since prior biologic therapy and recovered

          -  No concurrent biologic therapy

        Chemotherapy:

          -  No prior cytotoxic chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  Prior androgen-blockade therapy (e.g., luteinizing hormone-releasing hormone agonist
             and antiandrogen therapy) allowed if administered for a duration of less than 30 days

          -  Prior neoadjuvant hormonal therapy allowed

        Radiotherapy:

          -  At least 4 weeks since prior radiotherapy and recovered

          -  No concurrent radiotherapy

        Surgery:

          -  At least 4 weeks since prior surgery and recovered

        Other:

          -  No concurrent bisphosphonates