NCT01845675已完成2 期
Temozolomide or Dacarbazine-based Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor
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
- 14
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in well-differentiated pancreatic neuroendocrine tumor
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
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Pathologically confirmed locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumor.
- •Prior treatment with one-line chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine or endostatin within the past 6 months
- •Disease progressed during or after last therapy
- •Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
- •Disease progressed within the past 12 months。
- •Patients must have at least one measurable site of disease according to RECIST1.1 criteria that has not been previously irradiated.
- •Adequate bone marrow, liver and renal function
- •Life expectancy 3 months or more
- •Patient informed consent。
排除标准
- •Concurrent use of Octreotide or other drug that may have efficacy in neuroendocrine tumor.
- •2 or more lines of prior chemotherapy。
- •Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- •Uncontrolled infectious disease。
- •Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
- •Uncontrolled brain or leptomeningeal metastases
- •Patients with known hypersensitivity to temozolomide or endostatin。
- •Patient could not take tablets。
研究组 & 干预措施
temozolomide or dacarbazine-based chemotherapy, endostatin
Experimental
Endostatin 15mg/d，IV infusion, d1-d14 Temozolomide 150-200mg/m2/d，p.o., d1-d7 or dacarbazine 250mg/m2/d, IV infusion, d1-5, 5-FU 500mg/m2/d, IV infusion d1-5 Repeat every 3 weeks.
干预措施: temozolomide or dacarbazine-based chemotherapy, endostatin (Drug)
结局指标
主要结局
overall response rate
时间窗: up to 12 months
次要结局
- progression free survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- toxicities(Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
研究者
YueJuan Cheng
attending medical oncologist
Peking Union Medical College Hospital
研究点 (1)
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