Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
2009年5月29日 更新者：Eli Lilly and Company
A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer
The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer.
The collection of DNA is optional to the patient.
研究概览
研究类型
介入性
注册 (实际的)
37
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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Texas
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Dallas、Texas、美国、75204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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:
- Must have been diagnosed with either advanced or metastatic breast cancer.
- Chemotherapy has not been given for advanced or metastatic breast cancer.
- The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.
- Able to carry out work of a light nature (for example, light housework, office work).
- Must be at least 18 years old.
Exclusion Criteria:
- Have received prior bone marrow or peripheral stem cell transplantation.
- Have received prior chemotherapy for metastatic breast cancer.
- Are currently pregnant or breast-feeding.
- Have an active infection that your doctor decides will affect your safety.
- Are unable to take folic acid or vitamin B12.
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 |
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实验性的：一个
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600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
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 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Tumor Response
大体时间：every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
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every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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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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Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
大体时间：every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up
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Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).
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every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up
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Duration of Tumor Response
大体时间：every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.
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every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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Progression-Free Survival Time
大体时间：every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
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every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
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Overall Survival Time
大体时间：every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up
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Defined as the time from date of first dose to time of death due to any cause.
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every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up
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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。
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4月1日
初级完成 (实际的)
2007年12月1日
研究完成 (实际的)
2007年12月1日
研究注册日期
首次提交
2005年3月18日
首先提交符合 QC 标准的
2005年3月18日
首次发布 (估计)
2005年3月21日
研究记录更新
最后更新发布 (估计)
2009年6月1日
上次提交的符合 QC 标准的更新
2009年5月29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.
pemetrexed的临床试验
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IO BiotechMerck Sharp & Dohme LLC完全的