Clinical trial NCT00030654 (phase 3, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: bicalutamide, docetaxel, doxorubicin hydrochloride, estramustine phosphate sodium, flutamide, ketoconazole, paclitaxel, releasing hormone agonist therapy, vinblastine sulfate
SMILES: [H][C@]12SCC(C)=C(N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=C(O)C=C1)C(O)=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, [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], CC(C)C(=O)NC1=CC(=C(C=C1)[N+]([O-])=O)C(F)(F)F, OC(CN1C=NC=N1)(CN1C=NC=N1)C1=C(F)C=C(F)C=C1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of adenocarcinoma of the prostate

               -  Failed local treatments (surgery and/or radiotherapy and/or brachytherapy) as
                  defined by a rising prostate-specific antigen level of at least 2.0 ng/mL
                  (confirmed by 2 measurements at least 2 weeks apart) and a doubling time of 32
                  weeks or less

               -  No clinical or radiographic evidence of disease

               -  Original Gleason score of at least 7 OR Gleason score of 6 with capsular
                  penetration or positive seminal vesicles or lymph nodes

          -  No metastases

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Zubrod 0-1

        Life expectancy:

          -  Not specified

        Hematopoietic:

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

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

          -  Hemoglobin at least 10 g/dL

          -  No history of bleeding disorders that would contraindicate warfarin, including
             clotting factor defects

        Hepatic:

          -  Bilirubin no greater than 1.5 mg/dL

          -  AST/ALT no greater than 1.5 times upper limit of normal

        Renal:

          -  Creatinine no greater than 1.5 mg/dL

          -  Blood Urea Nitrogen (BUN) no greater than 1.2 times normal

        Cardiovascular:

          -  No symptomatic heart disease

          -  No history of myocardial infarction

          -  No history of thromboembolic events (e.g., deep vein thrombosis, symptomatic
             cerebrovascular events, or pulmonary embolism)

        Other:

          -  No other major medical or psychiatric illness that would preclude study entry

          -  No other prior or concurrent invasive malignancy within the past 5 years except
             superficial skin cancer

          -  No history of esophageal varices

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 6 weeks since prior vaccine therapy

        Chemotherapy:

          -  At least 5 years since prior chemotherapy

        Endocrine therapy:

          -  Prior adjuvant or neoadjuvant hormonal therapy of less than 8 months duration allowed

          -  At least 1 year since prior androgen therapy

        Radiotherapy:

          -  See Disease Characteristics

          -  At least 5 years since prior radiotherapy to sites other than prostate

        Surgery:

          -  See Disease Characteristics

        Other:

          -  Concurrent warfarin allowed

          -  Concurrent bisphosphonate therapy initiated prior to or after randomization allowed