Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma
2013年3月13日 更新者：Peng Yuan、PENG YUAN
An Open-label, Single-arm, Phase II Study to Assess the Efficacy and Safety of Endostar® (Recombinant Human Endostatin Injection) Plus Gemcitabine and Docetaxel in Treatment of Soft Tissue Sarcoma Patients With Pulmonary Metastases
The purpose of this exploratory phase II study is to assess the effectiveness and safety profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel in treatment of soft tissue sarcoma patients with pulmonary metastases.
研究概览
详细说明
Anticipated 30 subjects will be enrolled to receive Endostar, Gemcitabine and Docetaxel.
Endostar at a dosage of 7.5 mg/m2 will be administered on Day 1-14 of each cycle.
Gemcitabine (1000 mg/m2) will be administered on Day 1 and Day 8 of each cycle.
Docetaxel (75 mg/m2) will be administered on Day 2 of each cycle.
An individual cycle of therapy will be defined as a 3-week (21-day) period.
Cycles will be repeated every 3 weeks.
Multiple cycles may be administered until the subject is PD or until a maximum of 6 cycles.
Time-to-progression (TTP) will be assessed using the Kaplan Meier method.
Overall response rate (ORR) as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST (v1.1).
Evaluation of 1- and 2-year overall survival will also be performed.
Safety measures will be recorded using the NCI-CTCAE (v4.0).
研究类型
介入性
注册 (预期的)
30
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing、中国、100021
- 招聘中
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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接触：
- Peng Yuan, MD
- 电话号码：86-10-8778-8114
- 邮箱：yuanpeng01@hotmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age between 18-70 years, male or female.
- ECOG performance status <=2.
- Life expectancy >= 3 months.
- Histologically or cytologically confirmed soft tissue sarcoma (GIST excluded).
- Patients must have had a prior anthracycline and/or ifosfamide in either the adjuvant or metastatic setting but not more than one regimen.
- At least one measurable pulmonary metastasis tumor lesions according to RECIST 1.1 criteria.
- Laboratory values: Hemoglobin (Hb) >= 90 g/L and no blood transfusion within 14 days, Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, Platelet (Plt)>= 80 x 10^9/L, Total Bilirubin (Tbil)=< 1.5 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN or =< 5 x ULN if liver metastases are present, Serum creatinine (Cr) =< 1.0 x ULN, Endogenous creatinine clearance (Ccr)> 50 mL/min (Cockcroft-Gault).
- Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and be willing to use effective contraception during study and for 8 weeks after last IMP administration.
- Willingness to participate in study and sign informed consent form.
Exclusion Criteria:
- Females who are pregnant or breastfeeding or have Childbearing potential unwilling to use effective contraception.
- Prior therapy with Gemcitabine, Docetaxel and Endostar.
- Subjects participating in other clinical trials within 4 weeks before enrollment.
- Accompanied by rapid progress of organ invasions, e.g.lesion areas are great than one half of liver or lung or have liver dysfunction.
- Uncontrolled central nervous system disorder or psychiatric illness.
- Current, serious, clinically significant cardiac arrhythmias, symptomatic congestive heart failure, myocardial infarction before enrollment.
- Patients with abnormal bone marrow function: ANC < 1.5 x 10^9/L, Plt < 75 x 10^9/L, Hb < 90g/L.
- Patients with renal dysfunction: Cr > 1.5 x ULN.
- Patients with liver dysfunction: Tbil > 1.5 x ULN.
- Uncontrolled brain metastases.
- Unwillingness or inability to comply with the study protocol.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Endostar
Endostar, Gemcitabine, Docetaxel
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Endostar administered at 7.5 mg/m2, intravenously (IV), on Day 1-14 every 21 days for up to 4-6 consecutive cycles
其他名称：
Gemcitabine administered at 1000 mg/m2, intravenously (IV), on Day 1 and Day 8, every 21 days for up to 4-6 consecutive cycles
Docetaxel administered at 75 mg/m2, intravenously (IV), on Day 2, every 21 days for up to 4-6 consecutive cycles
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time-to-Progression
大体时间：Approximately 2 years
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Time to progression is defined as time from first study treatment dose to the progression disease.
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Approximately 2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Response Rate
大体时间：Approximately 2 years
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Approximately 2 years
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Evaluate 1-year and 2-year overall survival rates
大体时间：Approximately 2 years
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Approximately 2 years
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Safety measures
大体时间：Approximately 3 years
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Adverse events, Clinical and laboratory data including physical examinations, vital signs, ECG results, Use of concomitant medications
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Approximately 3 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Peng Yuan, MD、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年11月1日
初级完成 (预期的)
2015年4月1日
研究完成 (预期的)
2015年10月1日
研究注册日期
首次提交
2013年3月13日
首先提交符合 QC 标准的
2013年3月13日
首次发布 (估计)
2013年3月15日
研究记录更新
最后更新发布 (估计)
2013年3月15日
上次提交的符合 QC 标准的更新
2013年3月13日
最后验证
2013年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.