Phase I/II Dose Escalation Study of VELCADE® and Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer

Inclusion criteria Each patient must meet all of the following inclusion criteria to be enrolled in the study: * Patient has histologically-confirmed advanced and/or metastatic androgen-independent prostate cancer requiring anti-neoplastic treatment. * Previous or concurrent hormone therapy with a luteinizing hormone-releasing hormone analog (e.g., leuprolide) does not preclude enrollment in the study. * Patient has progressive measurable or evaluable disease, defined as meeting at least one of the following three criteria \[1\]: 1. Progressive measurable disease (changes in the size of lymph nodes or parenchymal masses on physical examination or x-ray). 2. Progressive bone metastasis \[presence of new lesion(s) on a bone scan\]. 3. Progressive PSA, as evidenced by two separate measurements taken at least one week apart and confirmed by a third, and if necessary, a fourth measurement. * If the third measurement is not greater than the second measurement, then a fourth measurement must be taken; the fourth measurement must be greater than the second measurement for the patient to be eligible for enrollment in the study. * The confirmatory PSA measurement (i.e., the third or, if applicable, fourth PSA measurement) must be greater than or equal to 5 ng/mL. * Patient is 18 years of age or older. * Patient has a Karnofsky performance status of 60% or greater. * Patient has a life expectancy of three months or longer. * Patient has all of the following pretreatment laboratory data within 14 days before the first study drug dose: * Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3. * Platelets greater than or equal to100,000/mm3. * Hemoglobin \>8.0 g/dL. * Serum creatinine less than or equal to 2.5 mg/dL. * Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care. * Patient agrees to use an acceptable barrier method for contraception from Screening through 90 days after the last study drug dose. \[It is recommended that female partners of male patients enrolled in this study also use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence).\] Exclusion criteria Patients meeting any of the following exclusion criteria are not to be enrolled in the study. * Patient has received chemotherapy within four weeks, nitrosoureas within six weeks, or antibody therapy within eight weeks of enrollment. * Patient has received radiation therapy within four weeks of enrollment. * Patient has not recovered from all toxic effects of previous chemotherapy or radiation or antibody therapy. * Patient received treatment with flutamide within four weeks of enrollment or nilutamide or bicalutamide within six weeks of enrollment. * Patient has had any major surgery within four weeks of enrollment. * Patient has a history of allergic reactions to diuretics or anti-emetics suggested to be administered in conjunction with study drug * Patient has a history of severe hypersensitivity reaction to docetaxel or other agents formulated with polysorbate 80. * Patient had a myocardial infarction within six months of enrollment or has uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia * Patient has uncontrolled brain metastases or central nervous system disease. * Patient has Grade 2 or higher peripheral neuropathy * Patient has any of the following pretreatment laboratory data within 14 days before the first study drug dose: * Total bilirubin \> than the upper limit of normal (ULN). * Alanine transaminase (ALT) and/or aspartate transaminase (AST) \>1.5 x the ULN concurrent with alkaline phosphatase \>2.5 x the ULN. * Alkaline phosphatase \>5 x the ULN, unless shown by fractionation to be bone-derived and AST, ALT, bilirubin, gamma glutamyl transferase (GGT), and 5'nucleotidase are \<1.5 x the ULN and bilirubin is within normal range. * Serum testosterone 50 ng/mL or higher. * Patient is HIV-infected. * Patient is hepatitis B surface antigen positive or has previously documented hepatitis C infection. * Patient has an uncontrolled intercurrent illness (e.g., active infection). * Patient has another serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.