Clinical trial NCT00728663 (phase 2, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: docetaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Metastatic adenocarcinoma of the prostate

          -  Must have received one of the following treatment schedules for at least 12 weeks
             prior to study therapy:

               -  Docetaxel 75 mg/m^2 on day 1 of a 21-day course

               -  Docetaxel 35 mg/m^2 on days 1, 8, and 15 of a 28-day course

          -  Must demonstrate hormone-resistance, defined as tumor progression after orchiectomy or
             during treatment with hormonal agents (i.e., luteinizing hormone-releasing hormone
             [LHRH] agonists)

          -  Elevated prostate-specific antigen (PSA) > 2 ng/mL and PSA progression after at least
             12 weeks treatment with docetaxel/prednisone, within 90 days after discontinuation of
             docetaxel/prednisone treatment, under continued hormonal treatment (i.e., LHRH
             agonists or orchiectomy), and meets 1 of the following criteria for PSA progression:

               -  PSA increase of ≥ 25% above the nadir

               -  PSA increase of ≥ 25% above the baseline if no decrease has been observed

                    -  The increase is a minimum of 2 ng/mL, and it is confirmed 1 week later

          -  No presence or history of CNS metastases

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-2

          -  Neutrophils ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  ALT ≤ 2.5 times ULN

          -  Creatinine clearance ≥ 30 mL/min

          -  Patient compliance and geographic proximity allow proper staging and follow-up

          -  Peripheral neuropathy < grade 2

          -  No prior malignancy within the past 5 years with the exception of localized
             nonmelanoma skin cancer or Ta or Tis bladder cancer

          -  No known hypersensitivity to trial drugs or any of their components

          -  No serious underlying medical condition that, in the judgment of the investigator,
             would preclude the patient's ability to participate in the trial (e.g., active
             autoimmune disease, uncontrolled or acute severe infection, or uncontrolled diabetes)

          -  No psychiatric disorder precluding understanding of information on trial related
             topics, giving informed consent, or interfering with oral drug intake compliance

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 2 weeks since prior radiotherapy

          -  More than 6 weeks since prior treatment with antiandrogens (i.e., flutamide or
             bicalutamide)

          -  No prior chemotherapy other than docetaxel for metastatic prostate cancer

          -  No other concurrent experimental drugs or other anticancer therapy

               -  Concurrent bisphosphonates and LHRH agonists allowed provided these medications
                  started at least 2 months prior to study therapy

          -  No treatment in a clinical trial within the past 30 days

          -  No prior treatment with drugs interacting with epidermal growth factor receptor (i.e.,
             cetuximab, panitumumab, gefitinib, erlotinib hydrochloride, or multi-tyrosine kinase
             inhibitors)

          -  No concurrent drugs that, according to the Swissmedic-approved product information,
             are contraindicated for use with the trial drugs