Liposome Encapsulated Docetaxel (LE-DT) in Patients With Solid Tumors
Liposome Encapsulated Docetaxel (LE-DT) is a novel proprietary delivery system of docetaxel developed by NeoPharm, Inc. In this Phase I study, the LE-DT was evaluated for the maximum tolerated dose and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of Liposome Encapsulated Docetaxel (LE-DT) in Patients With Advanced Solid Tumors|
- To evaluate the tolerability and safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]This Phase I, open-label, dose-escalation study was designed to determine the maximum tolerated dose (MTD) of LE-DT in patients with advanced cancer. LE-DT was administered by intravenous infusion, over 1 hour, once every 21 days until occurrence of disease progression or toxicity requiring early treatment discontinuation. Dose escalation was not done until the safety and tolerability at a given dose level has been confirmed.
- To evaluate the pharmacokinetic and anti-tumor effect [ Time Frame: 1 year ] [ Designated as safety issue: No ]The patients were evaluated for pharmacokinetic profile upto 48 hours post treatment after cycle 1. The anti-tumor effects were evaluated after every two cycles of treatment.
|Study Start Date:||February 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Intravenous infusion, Upto 5 dose levels have been studied i.e. 50, 65, 85, 110 and 132 mg/m2, Every 3 weeks
Other Name: Liposome Entrapped Docetaxel
Liposome Entrapped Doxetaxel (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 promoting the assembly and stabilization of microtubules and is used for the treatment of malignancies from breast, prostate, lung, gastric, head and neck. By removing toxic detergent used in Taxotere®, LE-DT showed reduced toxicity and comparable therapeutic efficacy in preclinical studies. In clinic, it is believed that LE-DT will offer advantages to the patient of fewer side effects at similar doses, and possibly greater effectiveness when used at higher doses. In addition, routine premedication to prevent hypersensitivity may not be required.
This study is designed to determine the following:
- The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of LE-DT.
- The pharmacokinetics of docetaxel following intravenous administration of LE-DT.
- Any anti-tumor effects of LE-DT.
Up to 5 dose levels have been studied.
|United States, Arizona|
|TGEN/Scottsdale Clinical Research Institute|
|Scottsdale, Arizona, United States, 85258|
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center, Georgetown University|
|Washington, District of Columbia, United States, 20057|
|Principal Investigator:||John L Marshall, MD||Georgetowm University Medical Center|