A phase II trial of docetaxel (Taxotere) in combination with PI88 for men with androgen independent prostate cancer

Lead in tolerance study (proceed to next dose level if no dose limiting toxicity) cohort 1: 190mg PI-88 4 days/week (sub cutaneously) + docetaxel 75 mg/msquared on day1 (D1)(Intravenous) (total weekly dose of PI-88 = 760 mg) cohort 2: 250 mg of PI-88 4 days/week + docetaxel 75 mg/msquared D1 (total weekly dose of PI-88 = 1000 mg) cohort 3: 190 mg PI-88 7 days/week + docetaxel 75 mg/msquared D1 (total weekly dose of PI-88 = 1330 mg) cohort 4: 250 mg PI-88 7 days/week + docetaxel 75 mg/msquared D1(total weekly dose of PI-88 = 1750 mg). Once dose established will proceed to the randomised phase 2 component comparing a Day1-7 (D1-7)PI88 protocol vs a day 1-4 PI 88 protocol. Patients will be randomly allocated to receive docetaxel intravenously (75mg/m2) on day 1 and PI-88 subcutaneous injections (250mg) 4 days/week over a 3 week cycle or Docetaxel intravenously (75mg/m2) on day 1 and PI-88 subcutaneous injections (130mg) 7 days/week over a 3 week cycle. Treatment will continue for as long as benefit is shown (stable or objective response) or until patients have evidence of disease progression or are withdrawn from study treatment for other reasons. This study will continue until a minimum of 35 patients are recruited to each treatment arm, and all patients have completed study treatment. The results from this study will determine the efficacy and feasibility of the combination of docetaxel, prenisone and 2 regimens of PI-88 in the treatment of Androgen Independent prostate cancer.