Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients With Advanced Cancer
|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: NCT00080418|
Recruitment Status : Completed
First Posted : April 2, 2004
Last Update Posted : July 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm||Drug: Liposome Entrapped Paclitaxel Easy to Use||Phase 1|
LEP-ETU is a new formulation of the anti-cancer agent paclitaxel for injection or Taxol (paclitaxel and Cremophor EL). Paclitaxel is a drug currently used for treating a broad range of cancers. Paclitaxel is thought to prevent cells from dividing and growing, resulting in cell death. This new formulation consists of paclitaxel associated with liposomes, which are microscopic membrane-like structures created from lipids (fats). It is believed that LEP-ETU will maintain or enhance the anti-tumor properties of paclitaxel, while offering advantages to the patient of a shorter infusion time, routine premedication not required, fewer side effects at similar doses, and possibly greater effectiveness, especially if higher doses can be delivered without an increase in side effects.
This study is designed to determine the following:
- The highest dose of LEP-ETU that can be given safely to patients.
- The pharmacokinetics of paclitaxel following intravenous infusion with LEP-ETU.
- Any anti-tumor effects of LEP-ETU.
Up to 8 dose levels will be studied. LEP-ETU will be given to patients by intravenous infusion over 90 minutes, once every 21 days, until their disease progresses or side effects occur requiring the treatments to end. Patients will be evaluated for safety and how well they tolerate the treatments.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation in Patients With Advanced Cancer|
|Study Start Date :||July 2003|
|Primary Completion Date :||July 2005|
|Study Completion Date :||June 2010|
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): NCT00080418
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, New Jersey|
|Cancer Institute of New Jersey - University of Medicine and Dentistry of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, Pennsylvania|
|Fox Chase Temple Cancer Center - Temple University|
|Philadelphia, Pennsylvania, United States, 19140|