Phase I Study of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation in Patients With Advanced Cancer
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Cancer Institute of New Jersey - University of Medicine and Dentistry of New Jersey||New Brunswick, New Jersey 08903|
|Fox Chase Temple Cancer Center - Temple University||Philadelphia, Pennsylvania 19140|