Liposome Encapsulated Docetaxel (LE-DT) in Patients With Solid Tumors (LE-DT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01151384|
Recruitment Status : Completed
First Posted : June 28, 2010
Last Update Posted : July 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: LE-DT||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Liposome Encapsulated Docetaxel (LE-DT) in Patients With Advanced Solid Tumors|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
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
- To evaluate the tolerability and safety [ Time Frame: 1 year ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151384
|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|