Phase IB Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma
2015年6月17日 更新者:New Mexico Cancer Care Alliance
1.1 To determine the recommended phase II dose for gemcitabine in combination with a fixed dose of docetaxel and bevacizumab.
1.2 To determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma 1.3 To determine the toxicity profile of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma
研究概览
详细说明
Because the combination of gemcitabine and docetaxel has shown impressive activity in soft tissue sarcoma, we hypothesize that the addition of an antiangiogenesis agent (bevacizumab) would enhance the anticancer activity, as shown in other tumor types.
研究类型
介入性
注册 (实际的)
38
阶段
- 阶段1
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
-
-
New Mexico
-
Albuquerque、New Mexico、美国、87131
- University of New Mexico
-
Albuquerque、New Mexico、美国、87102-3661
- Hematology Oncology Associates
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Santa Fe、New Mexico、美国、87505
- St. Vincent Regional Medical Center
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Santa Fe、New Mexico、美国、87508
- New Mexico Cancer Care Associates
-
-
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 及以上 (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:
- All patients, 18 years of age or older, with chemotherapy naive soft tissue sarcoma are eligible if there is measurable disease Prior surgery or radiotherapy for the primary tumor is allowed but needs to have been completed at least 2 weeks from entry, and patient should have completely recovered from the procedures.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have a Zubrod performance status of 0-2.
- Patients must sign an informed consent.
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
Exclusion Criteria:
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
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:非随机化
- 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 |
---|---|
实验性的:Cohort 1
1000mg/m2 gemcitabine
|
During the treatment phase, pts.
will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks.
This 4-week period is called a cycle of treatment.
The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period.
Pts. will then receive bevacizumab IV over a 30-minute period.
Pts. will receive this treatment once every 2 weeks.
Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects.
As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment
其他名称:
|
实验性的:Cohort 2
1250 mg/m2 gemcitabine
|
During the treatment phase, pts.
will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks.
This 4-week period is called a cycle of treatment.
The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period.
Pts. will then receive bevacizumab IV over a 30-minute period.
Pts. will receive this treatment once every 2 weeks.
Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects.
As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment
其他名称:
|
实验性的:Cohort 3
1500 mg/m2 gemcitabine
|
During the treatment phase, pts.
will receive the drug combination of gemcitabine, docetaxel, and bevacizumab every 2 weeks for a period of 4 weeks.
This 4-week period is called a cycle of treatment.
The treatment consists of receiving docetaxel IV over a 60-minute period and gemcitabine IV over a 30-minute period.
Pts. will then receive bevacizumab IV over a 30-minute period.
Pts. will receive this treatment once every 2 weeks.
Pts. will receive at least 2 cycles of treatment unless you have progression of your disease or unmanageable side effects.
As long as the size of pts.'s tumor stays the same or gets smaller, pts may continue receiving treatment
其他名称:
|
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 |
---|---|---|
Overall response rate (complete and partial responses).
大体时间:4 years
|
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0).
ORR is the sum of the percentages of patients achieving complete and partial responses
|
4 years
|
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。
调查人员
- 首席研究员:Claire Verschraegen, MD、University of New Mexico
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
2005年11月1日
初级完成 (实际的)
2010年11月1日
研究完成 (实际的)
2010年11月1日
研究注册日期
首次提交
2006年1月11日
首先提交符合 QC 标准的
2006年1月11日
首次发布 (估计)
2006年1月12日
研究记录更新
最后更新发布 (估计)
2015年6月19日
上次提交的符合 QC 标准的更新
2015年6月17日
最后验证
2015年6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.