Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With HRPC

Inclusion criteria

• Rising prostate specific antigen (PSA) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy.
• Patients must have metastatic disease by bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
• ECOG performance status 0 or 1
• Adequate hematologic function
• Adequate liver and renal function
• Able to swallow and retain oral medication.
• Patients enrolled into Cohort B must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising PSA, progression of disease per RECIST, or >2 new lesions on bone scan.
• Patients enrolled into Cohort B must have received at least two cycles of docetaxel. Minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule.
• At least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.

Exclusion criteria

• Patients enrolled into Cohort A must not have received prior chemotherapy for HRPC.
• Known history of or clinical evidence of central nervous system (CNS) metastases.
• Active secondary malignancy or history of other malignancy within the last 5 years.
• Prior history of radiation therapy to > 25% of the bone marrow
• Peripheral neuropathy of > Grade 2
• Uncontrolled concurrent illness
• Failure to recover fully, as judged by the investigator, from prior surgical procedures.
• Concurrent anti-cancer therapy other than docetaxel and prednisone.
• Patients must not be receiving concurrent anti-androgen hormonal therapy for HRPC (LHRH therapies are acceptable to maintain castrate levels of testosterone)