Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer
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:
- 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
- To evaluate the Progression-Free Survival (PFS)
- To evaluate the safety of LEP-ETU at 275 mg/m2 level, in particular peripheral neuropathy
- To evaluate the Overall Survival (OS)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-Label, Phase II Study of LEP-ETU for Efficacy and Safety in Patients With Metastatic Breast Cancer|
- Assessment of Overall Response Rate (ORR) following treatment of LEP-ETU at 275 mg/m2 dose [ Time Frame: 2 years ] [ Designated as safety issue: No ]The time frame is average. The patient will be treated once every 21 day cycle for 6 cycles. Disease status and tumor response/progression will be assessed based on the Response Evaluation Criteria in Solid Tumor (RECIST) after 2, 4 and 6 cycle. Patient will be followed for overall survival until death.
- LEP-ETU 275mg/m2 Induce Progression-Free Survival Assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]The time frame is average. The patient will be treated once every 21 day cycle for 6 cycles. Disease progression will be assessed after 2, 4 and 6 cycle. Patient will be followed for overall Survival until death.
|Study Start Date:||March 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
All patient will have baseline to confirm disease status. The disease progression/response is assessed inaccordance to the RECIST guidelines
275 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, 6 Cycles or until progression or unacceptable toxicity develops.
Other Name: Liposome Entrapped Paclitaxel Easy to Use
|Indo-American Cancer Institute and Research Center|
|Banjara Hills, Hyderabad, India|
|P.D. Hinduja Antional Hospital & Medical Research Center|
|Mahim, Mumbia, India|
|Jaslok Hospital and Research Center|