NCT01186731

Efficacy and Safety Study of LE-DT to Treat Locally Advanced or Metastatic Pancreatic Cancer

A Multicenter, Open-Label, Phase II Study of LE-DT for Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Liposome Entrapped Docetaxel (LE-DT)	110 mg/m2 (IV)in vein on day 1 of each 21 day cycle , 6 cycles, until progression or unacceptable toxicity

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-04-01
• Completion: 2011-12-01
• First posted: 2010-08-23
• Last updated: 2012-09-12

Locations

1 site across 1 country: United States