此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer (ZODIAC)

2016年8月24日 更新者：Genzyme, a Sanofi Company

A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC

This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy.

This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone.

All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer.

In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent.

Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients.

Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

1690

阶段

  • 第三阶段

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

  • 中国
      • Beijing、中国
        • Research Site
      • Chongqing、中国
        • Research Site
      • Guangzhou、中国
        • Research Site
      • Nanjing、中国
        • Research Site
      • Shanghai、中国
        • Research Site
      • Wuhan、中国
        • Research Site
  • 丹麦
      • Herlev、丹麦
        • Research Site
      • København Ø、丹麦
        • Research Site
      • Odense、丹麦
        • Research Site
      • Roskilde、丹麦
        • Research Site
      • Vejle、丹麦
        • Research Site
  • 加拿大
      • Quebec、加拿大
        • Research Site
    • Alberta
      • Edmonton、Alberta、加拿大
        • Research Site
    • New Brunswick
      • Moncton、New Brunswick、加拿大
        • Research Site
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大
        • Research Site
    • Ontario
      • Kitchener、Ontario、加拿大
        • Research Site
      • London、Ontario、加拿大
        • Research Site
      • Toronto、Ontario、加拿大
        • Research Site
    • Quebec
      • Laval、Quebec、加拿大
        • Research Site
  • 印度
      • Ahmedabad、印度
        • Research Site
      • Chennai、印度
        • Research Site
      • Hyderabad、印度
        • Research Site
      • Kolkata、印度
        • Research Site
      • New Delhi、印度
        • Research Site
      • Pune、印度
        • Research Site
      • Vellore、印度
        • Research Site
  • 印度尼西亚
      • Jakarta Timur、印度尼西亚
        • Research Site
      • Yogyakarta、印度尼西亚
        • Research Site
  • 墨西哥
      • Durango、墨西哥
        • Research Site
      • Morelia、墨西哥
        • Research Site
      • Toluca、墨西哥
        • Research Site
  • 大韩民国
      • Seoul、大韩民国
        • Research Site
  • 奥地利
      • Graz、奥地利
        • Research Site
      • Grimmenstein、奥地利
        • Research Site
      • Innsbruck、奥地利
        • Research Site
      • Linz、奥地利
        • Research Site
      • Wels、奥地利
        • Research Site
      • Wien、奥地利
        • Research Site
  • 巴西
      • Fortaleza、巴西
        • Research Site
      • Goiânia、巴西
        • Research Site
      • Porto Alegre、巴西
        • Research Site
      • Rio de Janeiro、巴西
        • Research Site
      • Sao Paulo、巴西
        • Research Site
  • 希腊
      • Athens、希腊
        • Research Site
      • Heraklion、希腊
        • Research Site
  • 德国
      • Bad Berka、德国
        • Research Site
      • Berlin、德国
        • Research Site
      • Essen、德国
        • Research Site
      • Großhansdorf、德国
        • Research Site
      • Halle、德国
        • Research Site
      • Hamburg、德国
        • Research Site
      • Heidelberg、德国
        • Research Site
      • Köln、德国
        • Research Site
      • Oldenburg、德国
        • Research Site
      • Ulm、德国
        • Research Site
      • Wiesbaden、德国
        • Research Site
  • 意大利
      • Ancona、意大利
        • Research Site
      • Avellino、意大利
        • Research Site
      • Bologna、意大利
        • Research Site
      • Genova、意大利
        • Research Site
      • Mantova、意大利
        • Research Site
      • Napoli、意大利
        • Research Site
      • Orbassano、意大利
        • Research Site
      • Parma、意大利
        • Research Site
      • Perugia、意大利
        • Research Site
      • Pisa、意大利
        • Research Site
      • Reggio Emilia、意大利
        • Research Site
  • 新加坡
      • Singapore、新加坡
        • Research Site
  • 日本
      • Akashi-shi、日本
        • Research Site
      • Fukuoka、日本
        • Research Site
      • Fukuoka-shi、日本
        • Research Site
      • Isehara-shi、日本
        • Research Site
      • Kobe-shi、日本
        • Research Site
      • Koto-ku、日本
        • Research Site
      • Kumamoto-shi、日本
        • Research Site
      • Matsuyama-shi、日本
        • Research Site
      • Nagoya-shi、日本
        • Research Site
      • Okayama-shi、日本
        • Research Site
      • Okazaki-shi、日本
        • Research Site
      • Osaka-shi、日本
        • Research Site
      • Osakasayama-shi、日本
        • Research Site
      • Sakai-shi、日本
        • Research Site
      • Sapporo-shi、日本
        • Research Site
      • Shinjuku-ku、日本
        • Research Site
      • Sunto-gun、日本
        • Research Site
      • Toyonaka、日本
        • Research Site
      • Ube-shi、日本
        • Research Site
      • Utsunomiya-shi、日本
        • Research Site
      • Yokohama-shi、日本
        • Research Site
  • 比利时
      • Brussels (Jette)、比利时
        • Research Site
      • Brussels (Woluwé-St-Lambert)、比利时
        • Research Site
      • Edegem、比利时
        • Research Site
      • Genk、比利时
        • Research Site
      • Liege、比利时
        • Research Site
  • 法国
      • Bordeaux Cedex、法国
        • Research Site
      • Boulogne Billancourt、法国
        • Research Site
      • Caen Cedex、法国
        • Research Site
      • Dijon、法国
        • Research Site
      • Nancy、法国
        • Research Site
      • Paris、法国
        • Research Site
      • Pierre Benite Cedex、法国
        • Research Site
      • Saint Herblain、法国
        • Research Site
  • 泰国
      • Chiang Mai、泰国
        • Research Site
  • 火鸡
      • Ankara、火鸡
        • Research Site
      • Istanbul、火鸡
        • Research Site
      • Izmir、火鸡
        • Research Site
  • 美国
    • California
      • Fullerton、California、美国
        • Research Site
      • Los Angeles、California、美国
        • Research Site
      • Northridge、California、美国
        • Research Site
    • Colorado
      • Colorado Springs、Colorado、美国
        • Research Site
    • Connecticut
      • Norwalk、Connecticut、美国
        • Research Site
    • Florida
      • Ocala、Florida、美国
        • Research Site
    • Georgia
      • Marietta、Georgia、美国
        • Research Site
    • Illinois
      • Joliet、Illinois、美国
        • Research Site
      • Park Ridge、Illinois、美国
        • Research Site
    • Kansas
      • Hutchinson、Kansas、美国
        • Research Site
    • Kentucky
      • Louisville、Kentucky、美国
        • Research Site
    • Massachusetts
      • Boston、Massachusetts、美国
        • Research Site
    • Michigan
      • Ann Arbor、Michigan、美国
        • Research Site
    • Missouri
      • St. Louis、Missouri、美国
        • Research Site
    • Nevada
      • Henderson、Nevada、美国
        • Research Site
    • New York
      • Albany、New York、美国
        • Research Site
      • Armonk、New York、美国
        • Research Site
      • New York、New York、美国
        • Research Site
    • North Carolina
      • Durham、North Carolina、美国
        • Research Site
      • Hickory、North Carolina、美国
        • Research Site
    • Oregon
      • Portland、Oregon、美国
        • Research Site
    • Texas
      • Austin、Texas、美国
        • Research Site
      • Houston、Texas、美国
        • Research Site
    • Utah
      • Ogden、Utah、美国
        • Research Site
    • Virginia
      • Alexandria、Virginia、美国
        • Research Site
      • Salem、Virginia、美国
        • Research Site
    • Washington
      • Vancouver、Washington、美国
        • Research Site
  • 荷兰
      • Amsterdam、荷兰
        • Research Site
      • Den Bosch、荷兰
        • Research Site
      • Groningen、荷兰
        • Research Site
      • Maastricht、荷兰
        • Research Site
  • 葡萄牙
      • Coimbra、葡萄牙
        • Research Site
      • Funchal、葡萄牙
        • Research Site
      • Lisboa、葡萄牙
        • Research Site
      • Porto、葡萄牙
        • Research Site
      • Vila Nova de Gaia、葡萄牙
        • Research Site
  • 西班牙
      • A Coruña、西班牙
        • Research Site
      • Alicante、西班牙
        • Research Site
      • Madrid、西班牙
        • Research Site
      • Málaga、西班牙
        • Research Site
      • Zaragoza、西班牙
        • Research Site
  • 越南
      • Hanoi city、越南
        • Research Site
      • Ho Chi Minh city、越南
        • Research Site
  • 阿根廷
      • Bahía Blanca、阿根廷
        • Research Site
      • Capital Federal、阿根廷
        • Research Site
      • Ciudad de Buenos Aires、阿根廷
        • Research Site
      • Mendoza、阿根廷
        • Research Site
      • Rosario、阿根廷
        • Research Site
  • 马来西亚
      • Kubang Kerian、马来西亚
        • Research Site
      • Nilai、马来西亚
        • Research Site
      • Penang、马来西亚
        • Research Site

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:

Lung cancer patients who answer true to the following statements are eligible to join this clinical study.

  • I have a confirmed diagnosis of locally advanced or metastatic non small cell lung cancer (Stage IIIb - IV)
  • I have had 1st line anti-cancer therapy. Previous treatment with Avastin (bevacizumab) in first line NSCLC is allowed.

Exclusion Criteria:

Lung cancer patients who answer true to the following are NOT eligible to join this clinical study.

  • I do not have non small cell lung cancer (NSCLC)
  • I have received treatment with docetaxel (Taxotere). Prior treatment with paclitaxel is acceptable.
  • I have received 2nd line anti-cancer therapy (For example, patients with previous 2nd line non small cell lung cancer (NSCLC) treatment with Tarceva (erlotinib, OSI-744), Alimta (pemetrexed) are not eligible)
  • I have been treated with VEGFR-tyrosine kinase inhibitors (TKIs) (sunitinib, sorafenib, other VEGF TKIs). Previous treatment with Avastin (bevacizumab) in 1st line non small cell lung cancer is permitted.
  • I have a history of uncontrolled irregular heartbeat
  • I have a history of high blood pressure which has not been controlled with medication If you are unsure of the meaning of the inclusion and exclusion criteria above, please contact the call center number for help.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：2个
凡德他尼 + 多西紫杉醇
药品：Docetaxel
infusion
其他名称：
  • TAXOTERE™
药品：Vandetanib
oral
其他名称：
  • ZD6474
  • ZACTIMA™
有源比较器：1
Docetaxel monotherapy
药品：Docetaxel
infusion
其他名称：
  • TAXOTERE™

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
Progression-Free Survival (PFS) in the Overall Population
大体时间：RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months
Progression-Free Survival (PFS) in the Female Population
大体时间：RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months

次要结果测量

结果测量
措施说明
大体时间
Overall Survival (OS) in the Overall Population
大体时间：Time to death in months
Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
Time to death in months
Overall Survival (OS) in the Female Population
大体时间：Time to death in months
Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
Time to death in months
Objective Response Rate (ORR)
大体时间：Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.
Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Disease Control Rate (DCR)
大体时间：RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Disease control rate is defined as the number of patients who achieved disease control at least 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 6 is assigned to patients who have not responded and have no evidence of progression at least 6 weeks after randomisation.
RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Duration of Response (DoR)
大体时间：RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)
RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).
大体时间：FACT-L questionnaires are to be administered every 3 weeks after randomisation

The lung cancer subscale (LCS) consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items.

Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.

A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days.
FACT-L questionnaires are to be administered every 3 weeks after randomisation
Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)
大体时间：FACT-L questionnaires are to be administered every 3 weeks after randomisation

The pulmonary symptom index (PSI) consists of 4 items of the LCS relating to pulmonary symptoms (i.e. 3 items relating to breathing/dyspnea, and 1 item relating to cough). The PSI score is the sum of the scores from the 4 items.

Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.

A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days.
FACT-L questionnaires are to be administered every 3 weeks after randomisation

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。

赞助

Genzyme, a Sanofi Company

调查人员

  • 研究主任：Contact-US@sanofi.com、Sanofi

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

有用的网址

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

2006年5月1日

初级完成 (实际的)

2008年8月1日

研究完成 (实际的)

2014年3月1日

研究注册日期

首次提交

2006年4月6日

首先提交符合 QC 标准的

2006年4月6日

首次发布 (估计)

2006年4月10日

研究记录更新

最后更新发布 (估计)

2016年9月30日

上次提交的符合 QC 标准的更新

2016年8月24日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D4200C00032
  • 6474IL/0032
  • 2005-004749-32 (EudraCT编号)

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.

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