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Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC) (OPUS)

2014年8月5日 更新者：Merck KGaA, Darmstadt, Germany

Open, Randomized, Controlled, Multicenter Phase II Study Comparing 5-FU/FA Plus Oxaliplatin (FOLFOX-4) Plus Cetuximab Versus 5-FU/FA Plus Oxaliplatin (FOLFOX-4) as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer

This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.

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)

344

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

  • 乌克兰
      • Dnepropetrovsk、乌克兰
        • Research Site
      • Kharkov、乌克兰
        • Research Site
      • Kiev、乌克兰
        • Research Site
      • Lviv、乌克兰
        • Research Site
      • Simferopol、乌克兰
        • Research Site
      • Vinnitsa、乌克兰
        • Research Site
  • 以色列
      • Haifa、以色列
        • Research Site
      • Kfar-Saba、以色列
        • Research Site
      • Petah Tiqva、以色列
        • Research Site
      • Rehovot、以色列
        • Research Site
      • Tel-Aviv、以色列
        • Research Site
      • Tel-Hashomer、以色列
        • Research Site
  • 俄罗斯联邦
      • Kazan、俄罗斯联邦
        • Research Site
      • Krasnodar、俄罗斯联邦
        • Research Site
      • Moscow、俄罗斯联邦
        • Research Site
      • Obninsk、俄罗斯联邦
        • Research Site
      • Samara、俄罗斯联邦
        • Research Site
      • St. Petersburg、俄罗斯联邦
        • Research Site
  • 奥地利
      • Graz、奥地利
        • Research Site
      • Linz、奥地利
        • Research Site
      • Salzburg、奥地利
        • Research Site
      • Wien、奥地利
        • Research Site
      • Zams、奥地利
        • Research Site
  • 希腊
      • Athens、希腊
        • Research Site
      • Loannina、希腊
        • Research Site
      • Thessaloniki、希腊
        • Research Site
  • 德国
      • Aschaffenburg、德国
        • Research Site
      • Dresden、德国
        • Research Site
      • Essen、德国
        • Research Site
      • Hamburg、德国
        • Research Site
      • Kiel、德国
        • Research Site
      • Magdeburg、德国
        • Research Site
      • Mannheim、德国
        • Research Site
      • Nürnberg、德国
        • Research Site
      • Tübingen、德国
        • Research Site
  • 意大利
      • Brescia、意大利
        • Research Site
      • Milano、意大利
        • Research Site
      • Padova、意大利
        • Research Site
      • Pavia、意大利
        • Research Site
      • Rome、意大利
        • Research Site
      • Torino、意大利
        • Research Site
  • 比利时
      • Antwerpen、比利时
        • Research Site
      • Bonheiden、比利时
        • Research Site
      • Brugge、比利时
        • Research Site
      • Hasselt、比利时
        • Research Site
      • Leuven、比利时
        • Research Site
      • Roeselare、比利时
        • Research Site
      • Turnhout、比利时
        • Research Site
      • ZU Gent、比利时
        • Research Site
  • 法国
      • Besancon、法国
        • Research Site
      • Clermond Ferrand、法国
        • Research Site
      • Clichy、法国
        • Research Site
      • Montpellier、法国
        • Research Site
      • Paris、法国
        • Research Site
      • Rouen、法国
        • Research Site
      • Strasbourg、法国
        • Research Site
  • 波兰
      • Bialystok、波兰
        • Research Site
      • Krakow、波兰
        • Research Site
      • Lublin、波兰
        • Research Site
      • Opole、波兰
        • Research Site
      • Poznan、波兰
        • Research Site
      • Szczecin、波兰
        • Research Site
      • Warszawa、波兰
        • Research Site
  • 罗马尼亚
      • Alba Iulia、罗马尼亚
        • Research Site
      • Bucurest、罗马尼亚
        • Research Site
      • Onesti、罗马尼亚
        • Research Site
      • Oradea、罗马尼亚
        • Research Site
      • Timisoara、罗马尼亚
        • Research Site
  • 葡萄牙
      • Lisbon、葡萄牙
        • Research Site
      • Santa Maira da Feira、葡萄牙
        • Research Site
  • 西班牙
      • Bilbao、西班牙
        • Research Site
      • Burgos、西班牙
        • Research Site
      • Girona、西班牙
        • Research Site
      • Madrid、西班牙
        • Research Site
      • Malaga、西班牙
        • Research Site
      • Orense、西班牙
        • Research Site
      • Reus、西班牙
        • Research Site
      • Valencia、西班牙
        • 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:

  • First-line mCRC
  • EGFR positive
  • Bi-dimensional measurable index lesion

Exclusion Criteria:

  • Previous exposure to EGFR-targeting therapy
  • Previous oxaliplatin-based therapy
  • Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
  • Radiotherapy
  • Surgery
  • Any other investigational drug in the 30 days before randomization
  • Brain metastasis and/or leptomeningeal disease
  • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cetuximab Plus FOLFOX-4
生物：Cetuximab

Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks).

Until progression or unacceptable toxicity develops
有源比较器：FOLFOX-4 Alone
药品：Oxaliplatin

Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks).

Until progression or unacceptable toxicity develops

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
Best Overall Response Rate - Independent Review Committee (IRC)
大体时间：Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006

次要结果测量

结果测量
措施说明
大体时间
Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)
大体时间：Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007
Best Overall Response Rate (KRAS Mutant Population)
大体时间：Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007
Progression-free Survival Time
大体时间：Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007

Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007
Progression-free Survival Time (KRAS Wild-Type Population)
大体时间：Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008

Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008
Progression-free Survival Time (KRAS Mutant Population)
大体时间：Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008

Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008
Overall Survival Time
大体时间：Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008
Overall Survival Time (KRAS Wild-Type Population)
大体时间：Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
Overall Survival Time (KRAS Mutant Population)
大体时间：Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
Participants With No Residual Tumor After Metastatic Surgery
大体时间：Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
No residual tumor after on-study surgery for metastases.
Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008
Disease Control Rate (Cut Off Date 4 August 2006)
大体时间：Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006
The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments as assessed by IRC (based on modified WHO criteria).
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006
Duration of Response
大体时间：Time from first assessment of Complete Response or Partial Response to disease progression,death or last tumor assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007

Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).

Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.
Time from first assessment of Complete Response or Partial Response to disease progression,death or last tumor assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007
Safety - Number of Patients Experiencing Any Adverse Event
大体时间：time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008
Please refer to Adverse Events section for further details
time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008

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

Merck KGaA, Darmstadt, Germany

调查人员

  • 首席研究员：Bokemeyer, Prof. Dr.、Klinik für Onkologie, Hämatologie und Knochenmarktransplantationen Universitätsklinikum Hamburg-Eppendorf, Germany

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

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7月1日

初级完成 (实际的)

2007年3月1日

研究完成 (实际的)

2010年11月1日

研究注册日期

首次提交

2005年7月28日

首先提交符合 QC 标准的

2005年7月28日

首次发布 (估计)

2005年7月29日

研究记录更新

最后更新发布 (估计)

2014年8月7日

上次提交的符合 QC 标准的更新

2014年8月5日

最后验证

2011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

  • EMR 62202-047

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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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Spain

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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