Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT01190982
First received: August 26, 2010
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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)

Condition Intervention Phase
Breast Cancer
Drug: LEP-ETU
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by INSYS Therapeutics Inc:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 70
Study Start Date: March 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEP-ETU
All patient will have baseline to confirm disease status. The disease progression/response is assessed inaccordance to the RECIST guidelines
Drug: LEP-ETU
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be 18 years or older and female.
  2. Have histologically or cytologically confirmed diagnosis of invasive adenocarcinoma originating in the breast.
  3. Have at least one target lesion per RECIST criteria
  4. 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.
  5. Have received prior chemotherapy in the adjuvant or metastatic setting with an anthracycline unless contraindicated.
  6. Have no other malignancy within the past five years, except non-melanoma skin cancer, cervical intraepithelial neoplasia (CIN), or in-situ cervical cancer (CIS).
  7. 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.
  8. 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).
  9. Have a life expectancy of greater than or equal to 12 weeks.
  10. Have an ECOG Performance status of 0-2.
  11. Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment.
  12. 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:

  1. Patient has radiographic evidence of active (symptomatic, untreated) intraparenchymal brain metastases; any leptomeningeal metastases; or asymptomatic untreated intraparenchymal brain metastases requiring treatment.
  2. Patient has received more than 1 prior treatment with a non-taxane agent in the metastatic setting.
  3. The only evidence of metastasis is lytic or blastic bone metastases or pleural effusion or ascites.
  4. Patient has a known infection with human immunodeficiency virus or active viral hepatitis.
  5. Patient has active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or uncontrolled arrhythmias.
  6. 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).
  7. Any active infection requiring parenteral or oral antibiotics.
  8. 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.
  9. Patient has pre-existing peripheral neuropathy of NCI-CTCAE Grade >1.
  10. Patient has received paclitaxel, docetaxel, or Abraxane because of metastatic carcinoma.
  11. Known hypersensitivity to paclitaxel, Cremophor EL, or liposomes.
  12. Pregnant or nursing female patients.
  13. Unwilling or unable to follow protocol requirements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190982

Locations
India
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
Mumbai, India
Sponsors and Collaborators
INSYS Therapeutics Inc
  More Information

No publications provided

Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT01190982     History of Changes
Other Study ID Numbers: LEP-ETU 202
Study First Received: August 26, 2010
Last Updated: August 23, 2012
Health Authority: United States: Food and Drug Administration
India: DCGI Office of Drug Controller General(India)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014