Salvage Therapy With Bevacizumab Plus Docetaxel and Cisplatin for Taiwanese Metastatic Breast Cancer
2009年12月2日 更新者:Taipei Medical University Hospital
Retrospective Analysis of Salvage Therapy With Bevacizumab Plus Docetaxel and Cisplatin for Taiwanese Metastatic Breast Cancer
Bevacizumab is a monoclonal antibody currently used for the treatment of colorectal cancer.
It works by preventing the formation of new blood vessels (angiogenesis).
The drug has been shown to inhibit vascular endothelial growth factor (VEGF) activity.
Previous research showed positive findings in other solid tumors that had metastasized.
In this study, the investigators are investigating the response of adding bevacizumab to conventional chemotherapy for metastatic breast cancer patients.
研究概览
详细说明
Targeted chemotherapy has gradually become the mainstay of cancer treatment in present day.
Targeted medications such as trastuzumab, bevacizumab and lapatinib have recently been more extensively adopted for many cancers, particularly breast cancer.
Among these targeted medications, bevacizumab is a monoclonal antibody acting on vascular endothelial growth factor receptor and it works by preventing the formation of new blood vessels (angiogenesis).
Published articles indicated that monotherapy of bevacizumab on breast cancer showed only a 9-17% response rate, while combining with paclitaxel, the treatment outcome appeared to improve progression-free survival and the objective response rate.
We are curious about the additive effect of bevacizumab on conventional chemotherapy, the toxicities induced when combined target therapy with conventional chemotherapy and the duration of remission that these treatment could achieve.
In this study, we utilized bevacizumab, docetaxel plus cisplatin for metastatic breast cancer patients and furthermore, we are evaluated the treatment response, toxicities and duration of remission as our main goals.
研究类型
介入性
注册 (实际的)
20
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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-
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Taipei、台湾、110
- Taipei Medical University Hospital
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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 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
- Normal left ventricular ejection fraction (LVEF).
- Age ≤ 65 years.
- At least one unidimensionally measurable lesion by imaging studies.
- AST/ALT 2.5 ULN (< 5 ULN if liver metastases).
- Serum bilirubin 3 ULN, Serum Creatinine 1.5 ULN.
- Urine dipstick of proteinuria <2+.
- Women of childbearing potential must have a negative serum pregnancy test.
Exclusion Criteria:
- Uncontrolled hypertension (systolic blood pressure > 160 mm Hg, diastolic blood pressure > 90 mm Hg).
- Prior exposure to bevacizumab.
- Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed), except bone metastasis.
- Evidence of bleeding diathesis or coagulopathy.
- Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. Stroke in the preceding six months.
- Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of bevacizumab with chemotherapy.
- Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
- Pregnancy (positive serum pregnancy test) and lactation. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the 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: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 |
---|---|
实验性的:metastatic breast cancer
Patients with histological or cytological proven metastatic breast cancer were recruited.
The previous hormonal therapy for metastatic breast cancer or cytotoxic therapy was allowed.
The Her2/Neu over-expressive status should be negative.
Patients with brain metastasis are excluded.
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Bevacizumab 8 mg/kg(over 60 minutes) on first day of first cycle, followed by 5 mg/kg on first day of the rest cycles, repeat every 2 weeks. docetaxel 45 mg/m2(over 60 minutes) on day 1 of each cycle, repeat every 2 weeks. cisplatin 50 mg/m2(over 4 hours) on day 1 of each cycle, repeat every 2 weeks.
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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Response Rate
大体时间:every 3 months
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every 3 months
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次要结果测量
结果测量 |
大体时间 |
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Time to Progression(TTP), Progression free survival, overall survival, safety, Quality of Life
大体时间:every 3 months
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every 3 months
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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。
调查人员
- 首席研究员:Cheng-Jeng Tai, M.D.、Section of Hematology-Oncology, Department of Medicine, Taipei Medical University Hospital
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。
一般刊物
- Miller KD, Sweeney CJ, Sledge GW Jr. Redefining the target: chemotherapeutics as antiangiogenics. J Clin Oncol. 2001 Feb 15;19(4):1195-206. doi: 10.1200/JCO.2001.19.4.1195.
- Moy B, Goss PE. Lapatinib: current status and future directions in breast cancer. Oncologist. 2006 Nov-Dec;11(10):1047-57. doi: 10.1634/theoncologist.11-10-1047.
- Chu E. Bevacizumab targeted therapy: validation of angiogenesis as a key target for advanced colorectal cancer. Clin Colorectal Cancer. 2004 May;4(1):16. doi: 10.3816/ccc.2004.n.006. No abstract available.
- Eniu A. Integrating biological agents into systemic therapy of breast cancer: trastuzumab, lapatinib, bevacizumab. J BUON. 2007 Sep;12 Suppl 1:S119-26.
- Caprioni F, Fornarini G. Bevacizumab in the treatment of metastatic colorectal cancer. Future Oncol. 2007 Apr;3(2):141-8. doi: 10.2217/14796694.3.2.141.
- Jubb AM, Hurwitz HI, Bai W, Holmgren EB, Tobin P, Guerrero AS, Kabbinavar F, Holden SN, Novotny WF, Frantz GD, Hillan KJ, Koeppen H. Impact of vascular endothelial growth factor-A expression, thrombospondin-2 expression, and microvessel density on the treatment effect of bevacizumab in metastatic colorectal cancer. J Clin Oncol. 2006 Jan 10;24(2):217-27. doi: 10.1200/JCO.2005.01.5388. Epub 2005 Dec 19.
- Link JS, Waisman JR, Nguyen B, Jacobs CI. Bevacizumab and albumin-bound paclitaxel treatment in metastatic breast cancer. Clin Breast Cancer. 2007 Oct;7(10):779-83. doi: 10.3816/CBC.2007.n.039.
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1月1日
初级完成 (实际的)
2009年9月1日
研究完成 (实际的)
2009年9月1日
研究注册日期
首次提交
2009年12月1日
首先提交符合 QC 标准的
2009年12月2日
首次发布 (估计)
2009年12月3日
研究记录更新
最后更新发布 (估计)
2009年12月3日
上次提交的符合 QC 标准的更新
2009年12月2日
最后验证
2009年12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.
Bevacizumab, docetaxel, cisplatin的临床试验
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Weill Medical College of Cornell University终止多形性胶质母细胞瘤 | 间变性星形细胞瘤 | 弥漫性脑桥脑胶质瘤 | 脑干胶质瘤 | 毛粘液样星形细胞瘤 | 脑干胶质瘤 | 脑纤维星形细胞瘤 | 混合性少突胶质细胞瘤-星形细胞瘤美国
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