LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere) is an anti-microtubule agent that prevents cell division. 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. In addition, docetaxel has shown positive activity of protein bound taxane therapy in treating patients with pancreatic cancer. The current Phase II study is designed to accomplish the following objectives: 1. Assess the antitumor effect of 110 mg/m2 LE-DT administered intravenous (IV) every three weeks in pancreatic cancer patients with locally advanced or metastatic disease 2. To evaluate the progression-free survival and overall survival 3. To correlate secreted protein acid rich in cysteine expression with tumor response 4. To evaluate the safety of LE-DT, in particular peripheral neuropathy, water retention as well as myelotoxicity 5. To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic endpoints, including toxicities.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
40
110 mg/m2 (IV)in vein on day 1 of each 21 day cycle , 6 cycles, until progression or unacceptable toxicity
Lombardi Cancer Center, Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Response rate of tumor size reduction at 110 mg/m2 LE-DT dose level
Measurable disease response will be assessed by radiographic method, CT or MRI, along with serum CA 19-9 after completed 2, 4 and 6 cycle.
Time frame: 1 year
SPARC tumor expression following the treatment of LE-DT at 110 mg/m2 dose level
SPARC tumor expression will be assessed as a potential predictor of tumor response
Time frame: 1 year
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