Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01190982|
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : August 24, 2012
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)
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: LEP-ETU||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Phase II Study of LEP-ETU for Efficacy and Safety in Patients With Metastatic Breast Cancer|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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
- Assessment of Overall Response Rate (ORR) following treatment of LEP-ETU at 275 mg/m2 dose [ Time Frame: 2 years ]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 ]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.
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): NCT01190982
|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|