NCT01186731已完成2 期
A Multicenter, Open-Label, Phase II Study of LE-DT for Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response rate of tumor size reduction at 110 mg/m2 LE-DT dose level
研究概览
简要总结
LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere) is an anti-microtubule agent that prevents cell division. By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced toxicity and comparable therapeutic efficacy in pre-clinical study. The clinical evidence obtained from the NeoPharm Phase I study shows fewer side effects and possibly administered at higher dose to induce greater effectiveness of LE-DT. In addition, docetaxel has shown positive activity of protein bound taxane therapy in treating patients with pancreatic cancer. The current Phase II study is designed to accomplish the following objectives:
- Assess the antitumor effect of 110 mg/m2 LE-DT administered intravenous (IV) every three weeks in pancreatic cancer patients with locally advanced or metastatic disease
- To evaluate the progression-free survival and overall survival
- To correlate secreted protein acid rich in cysteine expression with tumor response
- To evaluate the safety of LE-DT, in particular peripheral neuropathy, water retention as well as myelotoxicity
- To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic endpoints, including toxicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 years or older, male and female.
- •Patient has histopathologically confirmed diagnosis of adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded. Biopsy sample must be available for SPARC assay.
- •Patients must have clinical or radiographic evidence of locally advanced or metastatic pancreatic cancer with measurable disease.
- •Male or non-pregnant and non-lactating female:
- •If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (β hCG) documented within 72 hours of the first administration of study drug.
- •If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator.
- •Patient can be newly-diagnosed without prior treatment or have failed initial adjuvant treatment with either gemcitabine, 5-FU or capecitabine with or without radiation therapy.
- •Patient has the following blood counts at baseline:
- •ANC greater than or equal to 1500 per uL
- •Platelets greater than or equal to 100000 per uL
- •Hgb greater than or equal to 9 g per dL
- •Patient has the following blood chemistry levels at baseline:
- •AST (SGOT), ALT (SGPT) less than or equal to 2.5 times of the upper limit of normal range (ULN), unless liver metastases are present, then less than or equal 5 times of the ULN is allowed
- •Bilirubin less than or equal to 1.5 times of the ULN
- •Serum creatinine less than or equal to 1.5 times of the ULN or calculated clearance greater than or equal to 60 mL/min for patients with serum creatinine levels above the institutional normal value.
- •Patient has acceptable coagulation profile as indicated by a Prothrombin time (PT) and Partial Thromboplastin Time (PTT) within normal limits (plus or minus 15%) unless explained by the use of anticoagulants
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Patient has one or more metastatic lesions or locally advanced primary tumor measurable by CT or MRI.
- •Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form prior to receiving any study related procedure.
排除标准
- •Patient has known brain metastases.
- •Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- •Patient has known infection with HIV, hepatitis B, or hepatitis C.
- •Patient has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
- •Patient who have received any other treatment for pancreatic cancer including radiotherapy, chemotherapy or any investigational therapy with the exception of initial adjuvant treatment including either gemcitabine, 5-FU or capecitabine with or without radiation therapy
- •Patient has a history of allergy or hypersensitivity to the study drug.
- •Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
- •Patient has pre-existing peripheral neuropathy of Grade >1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
- •Patient is unwilling or unable to comply with study procedures.
- •Patient is enrolled in any other clinical or investigational trial.
研究组 & 干预措施
Liposome Entrapped Docetaxel (LE-DT)
Experimental
干预措施: Liposome Entrapped Docetaxel (LE-DT) (Drug)
结局指标
主要结局
Response rate of tumor size reduction at 110 mg/m2 LE-DT dose level
时间窗: 1 year
Measurable disease response will be assessed by radiographic method, CT or MRI, along with serum CA 19-9 after completed 2, 4 and 6 cycle.
次要结局
- SPARC tumor expression following the treatment of LE-DT at 110 mg/m2 dose level(1 year)
研究者
研究点 (1)
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