Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT00100139|
Recruitment Status : Completed
First Posted : December 24, 2004
Last Update Posted : July 4, 2011
In this study, Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) is being compared to Taxol® to examine whether the paclitaxel in these 2 formulations undergoes similar processing by the body. Safety and tolerability of LEP-ETU and Taxol will also be assessed. In this study, each patient will receive one intravenous infusion of LEP-ETU or Taxol, followed 3 weeks later by an infusion of the other drug, at the same dose and infusion duration. Multiple blood samples will be taken for analysis before, during, and after both drug infusions. Upon completing these 2 Cycles of treatment, eligible patients may enroll in an extension study (LEP-ETU-102B) to continue treatment with LEP-ETU.
LEP-ETU is a liposomal formulation of paclitaxel, a widely used anti-cancer drug. This LEP-ETU formulation of paclitaxel is being developed to potentially reduce toxicities associated with Taxol, by eliminating the drug formulation component polyoxyethylated castor oil (Cremophor® EL). In LEP-ETU, paclitaxel is associated with liposomes, which are microscopic membrane-like structures created from lipids (fats). Thus, the LEP-ETU formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm||Drug: Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Drug: Paclitaxel for injection (Taxol)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Two-Period Crossover, Clinical Bioequivalence Study Comparing the Pharmacokinetics of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation Versus Taxol® in Patients With Advanced Cancer|
|Study Start Date :||November 2004|
|Primary Completion Date :||November 2006|
|Study Completion Date :||June 2010|
- To determine whether LEP-ETU and Taxol are bioequivalent.
- To evaluate the pharmacokinetics of paclitaxel and major metabolites in plasma
- To assess the safety and tolerability of paclitaxel following intravenous administration of LEP-ETU and Taxol.
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): NCT00100139
|United States, New Jersey|
|Cancer Institute of New Jersey - University of Medicine and Dentistry of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|Allgemeines Krankenhaus St. Georg|
|Academisch Medisch Centrum|
|Leids Universitair Medisch Centrum|