- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01190982
Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer
A Multicenter, Open-Label, Phase II Study of LEP-ETU for Efficacy and Safety in Patients With 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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Mumbai, India
- Jaslok Hospital and Research Center
-
-
Hyderabad
-
Banjara Hills, Hyderabad, India
- Indo-American Cancer Institute and Research Center
-
-
Mumbia
-
Mahim, Mumbia, India
- P.D. Hinduja Antional Hospital & Medical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be 18 years or older and female.
- Have histologically or cytologically confirmed diagnosis of invasive adenocarcinoma originating in the breast.
- Have at least one target lesion per RECIST criteria
- If the patient has received adjuvant or neoadjuvant taxane therapy, the patient must not have relapsed with breast cancer within one year of completing this therapy.
- Have received prior chemotherapy in the adjuvant or metastatic setting with an anthracycline unless contraindicated.
- Have no other malignancy within the past five years, except non-melanoma skin cancer, cervical intraepithelial neoplasia (CIN), or in-situ cervical cancer (CIS).
Have the following hematology levels at Baseline:
- ANC greater than or equal to 1,500 x 106 cells/L;
- Platelets greater than or equal to 100 x 109 cells/L;
- Hgb greater than or equal to 90 g/L.
Have the following chemistry levels at Baseline:
- AST (SGOT), ALT (SGPT) less than or equal to 2.5 x ULN if no evidence of liver metastases;
- AST (SGOT), ALT (SGPT) less than or equal to 5 x ULN if liver metastases are present;
- Total bilirubin less than or equal to 26 micromol/L (1.5 mg/dL);
- Creatinine less than or equal to 177 micromol/L (2 mg/dL); or 24-hour
- Alkaline phosphatase less than or equal to 5 x ULN (unless bone metastasis is present in the absence of liver metastasis).
- Have a life expectancy of greater than or equal to 12 weeks.
- Have an ECOG Performance status of 0-2.
- Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment.
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee -approved written informed consent form prior to receiving any study related procedure.
Exclusion Criteria:
- Patient has radiographic evidence of active (symptomatic, untreated) intraparenchymal brain metastases; any leptomeningeal metastases; or asymptomatic untreated intraparenchymal brain metastases requiring treatment.
- Patient has received more than 1 prior treatment with a non-taxane agent in the metastatic setting.
- The only evidence of metastasis is lytic or blastic bone metastases or pleural effusion or ascites.
- Patient has a known infection with human immunodeficiency virus or active viral hepatitis.
- Patient has active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or uncontrolled arrhythmias.
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug (e.g., uncontrolled bleeding or bleeding diathesis).
- Any active infection requiring parenteral or oral antibiotics.
The patient receives treatment with any:
- Hormonal or other non-investigational agent therapy within 2 weeks prior to first dose of study drug;
- Herceptin, mitomycin, or nitrosoureas therapy within 6 weeks prior to first dose;
- Chemotherapy (except for palliative bisphosphonate therapy for bone pain which can be administered as clinically indicated) within 4 weeks prior to first dose study drug;
- Investigational drug or immunotherapy within 4 weeks prior to first dose study drug;
- Concurrent radiation therapy (except for palliative radiotherapy for
- Radiation therapy within 4 weeks prior to first dose of study drug.
- Patient has pre-existing peripheral neuropathy of NCI-CTCAE Grade >1.
- Patient has received paclitaxel, docetaxel, or Abraxane because of metastatic carcinoma.
- Known hypersensitivity to paclitaxel, Cremophor EL, or liposomes.
- Pregnant or nursing female patients.
- Unwilling or unable to follow protocol requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LEP-ETU
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEP-ETU 202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
Clinical Trials on LEP-ETU
-
INSYS Therapeutics IncCompletedNeoplasmsUnited States
-
INSYS Therapeutics IncCompletedNeoplasmUnited States, Germany, Netherlands
-
Mansoura UniversityRecruitingProstatic Hyperplasia With Urinary ObstructionEgypt
-
The Immunobiological Technology Institute (Bio-Manguinhos)...Oswaldo Cruz InstituteNot yet recruiting
-
IDRIAmerican Leprosy MissionsCompleted
-
Boston UniversityTerminatedBenign Prostatic HyperplasiaUnited States
-
Bahçeşehir UniversityRecruitingAnkle Injuries | Ankle Sprains | Kinesiophobia | Jumping From HeightTurkey
-
Giovanni FM Strippoli, MDCompleted