A Multicenter, Open-Label, Phase II Study of LEP-ETU for Efficacy and Safety in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Assessment of Overall Response Rate (ORR) following treatment of LEP-ETU at 275 mg/m2 dose
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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 >
- •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.
研究组 & 干预措施
LEP-ETU
All patient will have baseline to confirm disease status. The disease progression/response is assessed inaccordance to the RECIST guidelines
干预措施: LEP-ETU (Drug)
结局指标
主要结局
Assessment of Overall Response Rate (ORR) following treatment of LEP-ETU at 275 mg/m2 dose
时间窗: 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.
次要结局
- LEP-ETU 275mg/m2 Induce Progression-Free Survival Assessment(2 years)