Bevacizumab and Capecitabine in Treatment of Elderly Patients With Metastatic Breast Cancer
2010年9月3日 更新者:South Eastern European Research Oncology Group
Phase II Clinical Study of Bevacizumab in Combination With Capecitabine as First-line Treatment in Elderly Patients With Metastatic Breast Cancer
This is an open-label, single-arm, multicenter study of capecitabine and bevacizumab administered as first-line treatment of previously untreated elderly patients, older than 70 years, with metastatic or locally recurrent breast cancer.
研究概览
研究类型
介入性
注册 (预期的)
88
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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Split、克罗地亚、21000
- 招聘中
- Clinical Hospital Split, Center of oncology
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首席研究员:
- Eduard Vrdoljak, PhD MD
-
-
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
70年 及以上 (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:
- Signed informed consent obtained prior to initiation of any study specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the Protocol code: ML22373 Protocol SEEROG: version 1.2. Date: October 15, 2009 3 study requirements;
- Age ≥70 years;
- Pathologically confirmed and documented metastatic breast cancer or locally recurrent breast cancer not amenable to curative treatment. Complete radiology and tumor measurement workup must be completed within 4 weeks prior to first study treatment;
- Measurable disease according to RECIST criteria;
- HER2 negative disease;
- No prior treatment for metastatic or locally recurrent disease;
- Prior radiotherapy is allowed if delivered at least 2 weeks before enrolment in the study and for the relief of metastatic bone pain, and provided that no more than 30% of marrow bearing bone was irradiated and that target lesions were not included in the radiotherapy field;
- Not suitable for aggressive chemotherapy regimen in the opinion of the investigator;
- Performance status ECOG 0 - 2.
Exclusion Criteria:
- Any prior neoadjuvant or adjuvant treatment with anthracyclines completed less than 6 months prior to enrolment. The maximum cumulative dose received must not have exceeded 360 mg/m2 for doxorubicin or 720 mg/m2 for epirubicin. Prior anti-epidermal growth factor therapy is allowed;
- Concurrent hormonal therapy; however previous hormonal therapy is allowed for adjuvant, locally recurrent, or metastatic breast cancer if completed within ≥1 months prior to enrolment;
- History or clinical evidence of brain metastases. If there is any clinical suspicion of brain metastasis, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) of the brain must be conducted within 4 weeks prior to enrolment;
- Other malignancy (including primary brain tumors) within the Protocol code: ML22373 Protocol SEEROG: version 1.2. Date: October 15, 2009 4 last 5 years, which could affect the diagnosis or assessment of breast cancer, except for adequately treated carcinoma in situ of the cervix, squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer;
- Life expectancy < 12 weeks;
Any of the following abnormal values:
- Inadequate bone marrow function: hemoglobin (Hb) < 8.0 g/dL, absolute neutrophil count (ANC) < 1.5 x 109/L, or platelet count < 100 x 109/L;
- Inadequate liver function: AST/SGOT or ALT/SGPT > 2.5 x upper limit of normal (ULN) or > 5 x ULN in patients with liver metastases), serum alkaline phosphatase > 2.5 ULN or > 5 x ULN in patients with liver metastases, or > 10 x ULN in patients with bone metastases or total bilirubin > 2 x ULN;
- Moderate or severe renal impairment: creatinine clearance ≤50 mL/min (calculated according to the cockcroft and Gault formula; see Appendix 1), or serum creatinine > 1.5 x ULN;
- Chronic daily treatment with aspirin (> 325 mg/day) or clopidogrel (> 75 mg / day);
- Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids);
- Requirement for concurrent use of the antiviral agents sorivudine or brivudine;
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to enrolment, or anticipation of the need for major surgery during the course of the study treatment;
- Minor surgical procedures, within 24 hours prior to enrolment;
- Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study.
- Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease, including:
- Cerebrovascular accident/stroke (≤ 6 months prior to enrolment)
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)
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 |
---|---|---|
Time to treatment progression
大体时间:average 5 years
|
followed until death
|
average 5 years
|
次要结果测量
结果测量 |
大体时间 |
---|---|
overall response rate in patients with measurable disease at baseline
大体时间:average 5 years
|
average 5 years
|
safety and tolerability
大体时间:average 5 years
|
average 5 years
|
Clinical benefit (complete response, partial response and stable disease) in patients with measurable disease at baseline
大体时间:average 5 years
|
average 5 years
|
progression-free survival
大体时间:average 5 years
|
average 5 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。
合作者
调查人员
- 首席研究员:Eduard Vrdoljak, PhD MD、Clinical Hospital Split, Center of oncology, Croatia
- 首席研究员:Damir Vrbanec, PhD MD、Clinical Hospital Zagreb, Croatia
- 首席研究员:Katarina Petrakova, MD、Masaryk Memorial Cancer Institue, Brno, Czech Republic
- 首席研究员:Gyorgy Bodoky, PhD MD、FOVAROSI SZENT LASZLO KORHAZ-RENDELOINTEZET, ONKOLOGIAI OSZTALY, Budapest, Hungary
- 首席研究员:Tamas Pinter, MD、Petz, Aladar Korhaz, Onkoradiologiai Osztaly, Gyor, Hungary
- 首席研究员:Vladimir Todorović, MD、Oncology clinic, Clinical Center of Montenegro
- 首席研究员:Marek Wojtukiewicz, PhD MD、Department of Oncology Medical University, Bialystok, Poland
- 首席研究员:Tadeusz Pienkowski, PhD MD、Cancer Centre and Institute of Oncology Warsaw
- 首席研究员:Daniela Grecea, MD、"Prof Dr. I Chiricuta" Cluj Napoca Oncology Institute - Breast Cancer Center, Cluj Napoca, Romania
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
2010年5月1日
初级完成 (预期的)
2011年8月1日
研究注册日期
首次提交
2010年8月26日
首先提交符合 QC 标准的
2010年9月3日
首次发布 (估计)
2010年9月6日
研究记录更新
最后更新发布 (估计)
2010年9月6日
上次提交的符合 QC 标准的更新
2010年9月3日
最后验证
2010年8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.
Capecitabine and Bevacizumab的临床试验
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AstraZenecaSWOG Clinical Trials Partnerships; Daiichi Sankyo招聘中乳腺癌美国, 中国, 丹麦, 英国, 大韩民国, 加拿大, 德国, 意大利, 比利时, 西班牙, 日本, 法国, 台湾, 希腊, 巴西, 瑞典, 波多黎各
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USDA Grand Forks Human Nutrition Research CenterCalifornia Polytechnic State University-San Luis Obispo完全的
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Sykehuset Asker og BaerumUllevaal University Hospital完全的
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University of British ColumbiaSocial Sciences and Humanities Research Council of Canada完全的
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Dana-Farber Cancer Institute邀请报名