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

NCT01190982 | Completed Phase 2 DMC

• 1 other identifier: LEP-ETU 202
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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 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. 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. 2.To evaluate the Progression-Free Survival (PFS)
3. 3.To evaluate the safety of LEP-ETU at 275 mg/m2 level, in particular peripheral neuropathy
4. 4.To evaluate the Overall Survival (OS)

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of Overall Response Rate (ORR) following treatment of LEP-ETU at 275 mg/m2 dose

  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 Outcomes (1)

• LEP-ETU 275mg/m2 Induce Progression-Free Survival Assessment

  2 years

Study Arms (1)

LEP-ETU

EXPERIMENTAL

All patient will have baseline to confirm disease status. The disease progression/response is assessed inaccordance to the RECIST guidelines

Drug: LEP-ETU

Interventions

LEP-ETU DRUG

275 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, 6 Cycles or until progression or unacceptable toxicity develops.

Also known as: Liposome Entrapped Paclitaxel Easy to Use

LEP-ETU

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead

Study Sites (3)

Indo-American Cancer Institute and Research Center

Banjara Hills, Hyderabad, India

Location

P.D. Hinduja Antional Hospital & Medical Research Center

Mahīm, Mumbia, India

Location

Jaslok Hospital and Research Center

Mumbai, India

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 30, 2010
• Study Start: March 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 24, 2012

Record last verified: 2012-08

Locations

IN (3)