The Role of Erlotinib an Epidermal Growth Factor Receptor (EGFR) Inhibitor in the Treatment of Myelodysplastic Syndrome
2019年11月21日 更新者：University of Cincinnati
Phase II of Erlotinib an Epidermal Growth Factor Receptor Inhibitor in the Treatment of Myelodysplastic Syndrome
The purpose of this research study is to find out what effects, good and/or bad, Erlotinib has on Myelodysplastic syndrome.
Myelodysplastic syndrome is a group of blood diseases where the bone marrow (spongy space in long bones which is the factory for blood cell production) does not make enough blood cells and therefore there is a lack of healthy blood cells in the body.
This can result in anemia, risk for infection and/or bleeding..
研究概览
详细说明
MDS is a neoplastic clonal stem disorder characterized by bone marrow failure with cytopenia, dyslastic morphological features and tendency to progress to acute myeloid leukemia.
It is estimated that MDS is the most common hematological malignancy in the USA.
Several treatment options are available for MDS ranging from supportive care, growth factor use, chemotherapy, stem cell transplantation, and newer novel agents such as thalidomide, lenalidomide, and hypomethylating agents.
Each of the different available treatments for MDS work in certain subset and relatively small percentage of patients, keeping the door open for novel therapeutic strategies to be explored.
The NIH has published requests for applications on myeloproliferative and myelopdysplastic syndrome emphasizing the need for more research in this area.
研究类型
介入性
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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Ohio
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Cincinnati、Ohio、美国、45267
- University of Cincinnati
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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 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:
- Patients must have an established diagnosis of myelodysplastic syndrome (MDS) and have either symptomatic anemia (defined as hemoglobin less than 10.0 g/dl) or transfusion dependent anemia (defined as 4 units of blood in the last 60 days).
- Patients treated previously with 5-azacytidine, decitabine, thalidomide, revlimid, amifostine, hydroxyurea, Histone deacytlase inhibitors and arsenic trioxide are allowed. Prior treatment with cytokines (i.e., interferon, interleukin), colony stimulating factors, or hydroxyurea is also permitted. Patients should be 28 days off prior treatment.
- Patients with chronic myelomonocytic leukemia (CMML) are eligible.
- Patients must have a performance status of 0 - 2 by Zubrod performance status criteria.
- Pretreatment pathology materials must be available for morphologic review. Collection of blood and marrow specimens for pathology review must be completed within 28 days prior to registration
- All patients must be informed of the investigational nature of this study and must sign and give written consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
- Patients must not have undergone bone marrow or stem cell transplant.
- Patients must not have received prior remission induction chemotherapy as treatment for MDS.
- Patients must not have secondary or therapy related MDS
- Patients who are known HIV positive are not eligible for this study.
- Patients must not be pregnant or nursing because of the potential risks of the drugs used in this study. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for at least 2 years
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：Single Arm
All patients will receive 150 mg of Erlotinib
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150 mg, PO, QD beginning day 1 week 1.
Patients will receive treatment for 16 weeks as long as there is no evidence of disease progression.
In no response is noted after 16 weeks of treatment, patients will be taken off the study.
Patients achieving response (HI, CR, or PR) will continue on treatment until evidence of disease progression or relapse.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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First 20 patients will be evaluated for overall response rate (CR, PR or HI).
大体时间：Estimated to be about 1 year.
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Estimated to be about 1 year.
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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If the first analysis of 20 patients warrant further enrollment, an additional 15 eligible patients will be registered. If 8 or more of the 35 patients achieve CR, PR or HI, then Phase III study will be warranted.
大体时间：Estimated to be about 1 year.
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Estimated to be about 1 year.
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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。
合作者
调查人员
- 首席研究员：Carl W Siegrist, M.D.、University of Cincinnati
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2007年11月1日
初级完成 (实际的)
2009年4月1日
研究完成 (实际的)
2009年4月1日
研究注册日期
首次提交
2007年12月6日
首先提交符合 QC 标准的
2007年12月7日
首次发布 (估计)
2007年12月10日
研究记录更新
最后更新发布 (实际的)
2019年11月25日
上次提交的符合 QC 标准的更新
2019年11月21日
最后验证
2009年4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.