Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
LEP-ETU is a novel, proprietary delivery system of paclitaxel developed by NeoPharm, Inc.
Paclitaxel (currently marketed as Taxol) is an anti-microtubular network agent and is active
in a broad spectrum of malignancies. Paclitaxel has poor solubility. In order to enhance the
solubility, this drug is formulated with polyoxyethylated castor oil, which leading to
infusion-related hypersensitivity reactions. The NeoPharm LEP-ETU is formulated with a
mixture of well characterized, synthetic phospholipids and cholesterol. This design
eliminates the need for the oil. The LEP-ETU formulation has improved safety profile that is
necessary for administering higher doses than would commonly be used with Taxol. The clinical
evidence obtained from the NeoPharm Phase I study shows LEP-ETU is better tolerated than
Taxol, as indicated by a higher maximum-tolerated dose (MTD). The current Phase II study is
designed to accomplish the following objectives:
1. Assess the Overall Response Rate (ORR) of patients with metastatic breast cancer after
administered over 90 minutes at the dose of 275 mg/m2 LEP-ETU
2. To evaluate the Progression-Free Survival (PFS)
3. To evaluate the safety of LEP-ETU at 275 mg/m2 level, in particular peripheral
neuropathy
4. To evaluate the Overall Survival (OS)