Prostate Cancer Clinical Trial
Official title:
A Multicenter, Open-Label, Phase II Study of LE-DT for Efficacy and Safety in Patients With 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)
n/a
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