Clinical trial NCT00027859 (phase 3, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: docetaxel, estramustine phosphate sodium, ketoconazole, therapeutic hydrocortisone
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(OC(=O)N(CCCl)CCCl)C=C3CC[C@@]21[H], OC(CN1C=NC=N1)(CN1C=NC=N1)C1=C(F)C=C(F)C=C1, [H][C@@]12CC[C@](O)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate that was continuously treated
             with androgen suppression

          -  Rising prostate-specific antigen (PSA), defined as PSA > 5 ng/mL, rising on 2
             consecutive measurements at least 4 weeks apart

          -  Gleason score 7 or higher and/or seminal vesicle involvement at diagnosis

          -  Patients previously treated with antiandrogen or glucocorticoid therapy must meet the
             following criteria:

               -  Must show a continued rise in PSA after stopping antiandrogen (flutamide,
                  bicalutamide, or nilutamide) or glucocorticoid (dexamethasone or prednisone)

                    -  At least 4 weeks continued rise in PSA after flutamide or nilutamide (6
                       weeks for bicalutamide)

          -  Testosterone less than 50 ng/dL

               -  Patients who have not undergone surgical castration must continue primary
                  androgen suppression to maintain castrate levels of testosterone

          -  No progressive or measurable local or metastatic disease (including bone metastases)

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  ECOG 0-1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Granulocyte count at least 2,000/mm^3

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

        Hepatic:

          -  SGOT no greater than 2 times upper limit of normal

          -  Bilirubin no greater than 1.5 mg/dL

        Renal:

          -  Creatinine no greater than 1.7 mg/dL

        Cardiovascular:

          -  No American Heart Association class III or IV heart disease

          -  No uncontrolled congestive heart failure

          -  No life-threatening cardiac arrhythmias

        Other:

          -  Fertile patients must use effective contraception

          -  No other prior malignancy unless curatively treated and disease-free for appropriate
             time period for specific cancer

          -  No preexisting peripheral neuropathy greater than grade 1

          -  No known hypersensitivity to polysorbate 80

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  At least 5 years since prior systemic chemotherapy

        Endocrine therapy:

          -  See Disease Characteristics

          -  At least 4 weeks since prior hydrocortisone

          -  No prior ketoconazole

        Radiotherapy:

          -  At least 28 days since prior radiotherapy to primary site

          -  No prior palliative radiotherapy

          -  No concurrent radiotherapy

        Surgery:

          -  See Disease Characteristics

        Other:

          -  Recovered form prior therapy

          -  At least 7 days since prior parenteral antibiotics for active infection

          -  No concurrent digitalis

          -  No concurrent H_2 blockers or proton pump inhibitors (arm I only)

          -  Concurrent bisphosphonates allowed provided they were initiated prior to study therapy