Pilot Efficacy Study of PI-88 With Docetaxel to Treat Prostate Cancer

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