Clinical trial NCT00268593 (phase 2, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: pi-88, 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:

        Inclusion Criteria:

          -  Histologically/cytologically proven prostate adenocarcinoma that is unresponsive or
             refractory to hormone therapy

          -  Patients must have received prior hormonal therapy, defined as castration by
             orchiectomy and/or luteinizing hormone releasing hormone (LHRH) agonists

          -  Patients must have documented progression detected by PSA increase, physical
             examination and/or imaging

          -  Patients must have achieved stable pain control for a minimum of seven consecutive
             days prior to study entry.

          -  Prior radiation therapy (to < 25% of the bone marrow only) is permitted. At least 4
             weeks must have elapsed since the completion of radiation therapy and the patient must
             have recovered from side effects prior to study entry.

          -  Prior surgery is allowed. At least 4 weeks must have elapsed since the completion of
             surgery

          -  Life expectancy > 3 months

          -  ECOG Performance score of < 2.

          -  Neutrophil count > 1.5 x 109/L (1,500/mm3)

          -  Haemoglobin > 10 g/dL

          -  Platelet count > 100 x 109/L (100,000/mm3)

          -  Total bilirubin < the upper limit of normal (ULN) of the institution

          -  ALT (SGPT) and AST (SGOT) < 1.5 x the ULN of the institution

          -  Calculated creatinine clearance, using Cockroft and Gault formula, >60 mL/min

          -  APTT and PT < 1.5 X ULN

          -  Patients (or legally acceptable representative) must have voluntarily given written
             informed consent to participate in this study.

          -  Patients must be willing to comply with the scheduled visit, treatment plans,
             laboratory tests, and other study procedures

        Exclusion Criteria:

          -  Prior cytotoxic chemotherapy

          -  Prior isotope therapy (e.g., strontium, samarium)

          -  Prior radiotherapy to >25% of bone marrow (whole pelvic irradiation is not allowed)

          -  Prior treatment with biological response modifiers within the previous 4 weeks

          -  Prior malignancy except the following: adequately treated basal cell or squamous cell
             skin cancer, or any other cancer from which the patient has been disease-free for > 5
             years

          -  Known brain or leptomeningeal involvement

          -  Symptomatic peripheral neuropathy > grade 2 according to the NCI Common Terminology
             Criteria for Adverse Events v3 (NCI CTCAE v3)

          -  Serious intercurrent medical illness that does not permit adequate follow-up and
             compliance with the study protocol

          -  History of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or
             other platelet disease, or laboratory evidence of anti-heparin antibodies

          -  Use of drugs that may inhibit the metabolism of docetaxel (cyclosporin, terfenadine,
             ketoconazole, erythromycin, troleandomycin) within the previous week or during the
             study

          -  Concurrent treatment with other experimental drugs. Participation in another clinical
             trial with any investigational drug within 30 days prior to study screening

          -  Treatment with any other anti-cancer therapy (except LHRH agonists) including any
             prescribed compounds and/or over-the-counter (OTC) products for the treatment of
             prostate cancer must be stopped prior to day of enrolment

          -  Treatment with systemic corticosteroids used for reasons other than specified by the
             protocol must be stopped prior to day of enrolment

          -  Concomitant bisphosphonate therapy is not allowed. Patients already receiving
             bisphosphonates must be stopped prior to day of enrolment

          -  Concomitant use of aspirin (> 150 mg/day), non-steroidal anti-inflammatory drugs
             (except specific COX-2 inhibitors), heparin, low molecular weight heparin (LMWH),
             warfarin (> 1 mg/day) or anti-platelet drugs (abciximab, clopidogrel, dipyridamole,
             ticlopidine and tirofiban). Low-dose aspirin (≤ 150 mg/day) and low-dose warfarin (≤ 1
             mg/day) are permitted as concomitant medications

          -  Treatment with heparin or low molecular weight heparin within the previous two weeks
             is not permitted

          -  History of allergy and/or hypersensitivity to heparin or other
             anti-coagulants/thrombolytic agents

          -  History of acute or chronic gastrointestinal bleeding within the last two years,
             inflammatory bowel disease or other abnormal bleeding tendency

          -  Patients at risk of bleeding due to open wounds or planned surgery

          -  Myocardial infarction, stroke or congestive heart failure within the past three months

          -  Uncontrolled or serious infection within the past four weeks