NCT00111904已完成2 期
Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer
Theradex9 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2005年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 9
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.
详细描述
OBJECTIVES:
- Determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (Genexol^®-PM).
- Determine the best overall response rate and duration of response in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Determine the clinical benefit and safety of this drug in these patients.
OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol^®-PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed epithelial carcinoma of the pancreas
- •Unresectable* locally advanced or metastatic disease NOTE: *Documented by high-quality contrast-enhanced CT scan
- •No known or clinical evidence of CNS metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ
- •No unstable or serious medical condition
- •No psychiatric disorder that would preclude giving informed consent
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for pancreatic cancer
- •Prior fluorouracil as a radiosensitizer allowed
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 6 weeks since prior radiotherapy for pancreatic cancer
- •Disease must have progressed after completion of radiotherapy
- •More than 14 days since prior major surgery and recovered
- •More than 30 days since prior investigational agents
排除标准
- 未提供
结局指标
主要结局
Overall survival
Clinical benefit
Safety
Time to progression
Time to treatment failure
Best overall response rate
次要结局
未报告次要终点
研究者
研究点 (9)
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