An Open Label, Randomized, Phase II Study of AS1404 in Combination With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer
The purpose of this trial is to confirm a safe dose of AS1404, to be given with docetaxel, and to see whether adding AS1404 and docetaxel together improves the outcome of the treatment, when compared to docetaxel alone.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : AS1404 (DMXAA)
Phase: Phase 2
Ages Eligible For Study:
- Age equal to, or greater than 18 years - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Life expectancy greater than or equal to 3 months - Histopathologically confirmed adenocarcinoma of the prostate - Metastatic progressive androgen-independent prostate cancer with no previous chemotherapy treatment - At least 4 weeks off of flutamide and 6 weeks off of bicalutamide and nilutamide - Patients who have not undergone surgical castration must continue treatment with an luteinizing hormone-releasing hormone (LHRH) agonist. In those patients where, for some reason, the LHRH agonist has been discontinued prior to entry on the study, it should be reinstituted and disease progression must be documented. - Hematological and biochemical indices at screening within the following ranges: - An absolute neutrophil count of greater than or equal to 1.5 x 10^9/L; - A platelet count of greater than or equal to 100 x 10^9/L; - A hemoglobin level of greater than or equal to 10 g/dL. - Adequate hepatic and renal function, as defined by: - Serum bilirubin less than or equal to upper limit of normal (ULN); - SGOT and/or SGPT less than or equal to 1.5 x ULN concomitant with alkaline phosphatase less than or equal to 2.5 x ULN; - Serum creatinine less than or equal to 120 micromol/L or creatinine clearance greater than or equal to 60 mL/min. - Be willing and able to provide written informed consent and, in the opinion of the Investigator, be able to comply with the study assessments and follow-up - Serum testosterone no greater than 50 ng/mL (chemically castrated patients only)