Clinical trial NCT00096304 (phase 1, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: docetaxel, epirubicin hydrochloride
SMILES: [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
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate

          -  Meets 1 of the following criteria:

               -  Measurable disease with any prostate-specific antigen (PSA) value

                    -  Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥
                       10 mm by spiral CT scan

                    -  Histologic confirmation required if measurable disease is confined to a
                       solitary lesion

               -  Non-measurable disease with PSA ≥ 5 ng/mL*

                    -  The following are considered non-measurable disease:

                         -  Bone lesions

                         -  Pleural or pericardial effusion

                         -  Ascites

                         -  CNS lesions

                         -  Leptomeningeal disease

                         -  Irradiated lesions unless disease progression was documented after
                            prior radiotherapy NOTE: *Patients with PSA ≥ 5 ng/mL only are not
                            eligible

          -  Progressive systemic disease despite ≥ 1 prior standard endocrine therapy with
             orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist, or
             diethylstilbestrol, as indicated by 1 of the following criteria:

               -  Objective evidence of increase > 20% in the sum of the longest diameters of
                  target lesions from the time of maximal regression OR the appearance of 1 or more
                  new lesions

               -  One or more new lesions on bone scan secondary to prostate cancer AND PSA ≥ 5
                  ng/mL

               -  Elevated PSA (≥ 5 ng/mL) with 2 consecutive increases from baseline (taken ≥ 1
                  week apart)

          -  Serum testosterone ≤ 50 ng/dL for patients without bilateral orchiectomy

               -  Patients who have not had a bilateral orchiectomy should continue therapy with
                  primary testicular androgen suppression (e.g., LHRH analogues)

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Granulocyte count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Meets 1 of the following criteria:

               -  AST or ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN)

               -  AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN

               -  AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal

          -  Bilirubin normal

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Cardiovascular

          -  No uncontrolled high blood pressure

          -  No unstable angina

          -  No symptomatic congestive heart failure

          -  No myocardial infarction within the past 6 months

          -  No serious uncontrolled cardiac arrhythmia

          -  No New York Heart Association class III or IV heart disease

        Other

          -  Fertile patients must use effective contraception during and for at least 3 months
             after study participation

          -  No peripheral neuropathy ≥ grade 2

          -  No prior severe hypersensitivity reaction to docetaxel or other drug formulated with
             polysorbate 80

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

        Chemotherapy

          -  No prior chemotherapy, including estramustine or suramin for prostate cancer

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior antiandrogen therapy

          -  No concurrent hormonal therapy except steroids for adrenal insufficiency, hormones for
             non-disease-related conditions (e.g., insulin for diabetes), or intermittent
             dexamethasone as an antiemetic

        Radiotherapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy

          -  At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam
             pentasodium

          -  No concurrent palliative radiotherapy

        Surgery

          -  See Disease Characteristics

          -  At least 4 weeks since prior surgery and recovered