A Phase 1 Study of Liposome Encapsulated Docetaxel (LE-DT) in Patients With Advanced Solid Tumors
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the tolerability and safety
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.
John L Marshall, MD
Georgetowm University Medical Center
United States: Food and Drug Administration
|Lombardi Comprehensive Cancer Center, Georgetown University||Washington, District of Columbia 20007|
|TGEN/Scottsdale Clinical Research Institute||Scottsdale, Arizona 85258|