Clinical trial NCT00255606 (phase 3, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: docetaxel, prednisone
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate

               -  Metastatic disease by imaging or clinical examination

          -  Hormone-refractory disease, defined as prostate-specific antigen (PSA) level > 10 µg/L
             AND rising between 2 sequential measurements

          -  Testosterone within castration levels by orchiectomy or medical castration comprising
             luteinizing hormone-releasing hormone (LHRH) analogues

        PATIENT CHARACTERISTICS:

        Age

          -  Over 18

        Performance status

          -  WHO 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Neutrophil count ≥ 1,500/mm^3

          -  Hemoglobin ≥ 11.0 g/dL

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  ALT and AST ≤ 2.5 times upper limit of normal (ULN)

          -  Bilirubin normal

          -  Alkaline phosphatase ≤ 6 times ULN (unless due to the presence of extensive bone
             disease)

          -  No serious liver disease

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Cardiovascular

          -  No ischemic or thromboembolic cardiac disease

          -  No myocardial infarction within the past 12 months

          -  No other serious cardiac disease

        Pulmonary

          -  No pulmonary emboli

        Immunologic

          -  No active infection

          -  No autoimmune disease, including any of the following:

               -  Lupus

               -  Scleroderma

               -  Rheumatoid polyarthritis

        Other

          -  No active peptic ulcer

          -  No unstable diabetes mellitus

          -  No contraindication to corticosteroids

          -  No other malignant disease within the past 5 years except basalioma

          -  No functional iron deficiency (i.e., transferrin saturation < 20%) that cannot be
             treated with iron supplementation

          -  No other serious illness or medical condition

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 2 months since prior recombinant human epoetin alfa or any other
             erythropoiesis-stimulating drug

        Chemotherapy

          -  At least 3 weeks since prior estramustine

        Endocrine therapy

          -  See Disease Characteristics

          -  At least 3 weeks since prior antiandrogen treatment

          -  Concurrent chemical castration with LHRH allowed provided patient has begun treatment
             prior to study entry

               -  No initiation of chemical castration therapy during study treatment

        Radiotherapy

          -  No prior radiotherapy to > 25% of bone marrow

          -  No prior radioisotope therapy

          -  Concurrent local palliative radiotherapy for pain allowed

        Surgery

          -  See Disease Characteristics

          -  At least 4 weeks since prior surgery

        Other

          -  No other prior cytostatic treatment

          -  Concurrent bisphosphonates allowed provided patient has begun treatment prior to study
             entry

               -  No initiation of bisphosphonates during study treatment