Efficacy and Safety Study of LE-DT to Treat Metastatic Castrate Resistant Prostate Cancer

LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere) is an anti-microtubular network agent and is one of the most active agents in the treatment of metastatic castrate resistant prostate cancer (CRPC) and other variety of cancers. Taxotere has poor solubility and is designed to be administered with Tween 80 in ethanol. This vehicle causes acute hypersensitivity reaction. By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced toxicity and comparable therapeutic efficacy in pre-clinical study. The clinical evidence obtained from the NeoPharm Phase I study shows fewer side effects and possibly administered at higher dose to induce greater effectiveness of LE-DT. The current Phase II study is designed to accomplish the following objectives: 1. Assess the antitumor effect indicator serum prostate specific antigen (PSA) following the intravenous (IV) administration of 110 mg/m2 LE-DT every three weeks in patients with metastatic castrate resistant prostate cancer 2. To evaluate the measurable soft tissue disease response using the response evaluation criteria in solid tumor (RECIST) methodology 3. To evaluate the progression-free survival (PFS) and overall survival (OS) 4. To correlate PSA expression with tumor response 5. To evaluate the safety of LE-DT at 110 mg/m2 level, in particular peripheral neuropathy, water retention as well as myelotoxicity 6. To evaluate the quality of life (QOL)