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

NCT01188408 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-03-12

No results posted yet for this study

Summary

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)

Conditions

Interventions

DRUG

Liposome Entrapped Docetaxel (LE-DT)

110 mg/m2 IV (in vein) on day 1 of each 21 day cycle, 6 cycles or until disease progression or unacceptable toxicity

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Nancy A Dawson, M.D. · Georgetown University

  • Brendan D Curti, M.D. · Providence Health & Services

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01188408 on ClinicalTrials.gov