Status:
COMPLETED
Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer
Lead Sponsor:
INSYS Therapeutics Inc
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 spectr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01190982
Start Date
March 1 2008
End Date
December 1 2011
Last Update
August 24 2012
Active Locations (3)
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1
Indo-American Cancer Institute and Research Center
Banjara Hills, Hyderabad, India
2
P.D. Hinduja Antional Hospital & Medical Research Center
Mahīm, Mumbia, India
3
Jaslok Hospital and Research Center
Mumbai, India