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A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer

2015年1月7日 更新者：Hoffmann-La Roche

A Randomised, Open-label Phase III Study to Assess Efficacy and Safety of Bevacizumab in Combination With Capecitabine as First-line Treatment for Elderly Patients With Metastatic Colorectal Cancer

This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) alone.

No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study.

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)

280

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4N2
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 4E6
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 2Y9
    • Ontario
      • London、Ontario、加拿大、N6A 4L6
      • Ottawa、Ontario、加拿大、K1H 8L6
      • Toronto、Ontario、加拿大、M4N 3M5
      • Toronto、Ontario、加拿大、M5B 1W8
    • Quebec
      • Montreal、Quebec、加拿大、H3T 1E2
  • 匈牙利
      • Budapest、匈牙利、1122
      • Budapest、匈牙利、1083
      • Gyor、匈牙利、9023
      • Zalaegerszeg-Pozva、匈牙利、8900
  • 墨西哥
      • Leon、墨西哥、37000
      • Mexico City、墨西哥、14000
      • Mexico City、墨西哥、14140
      • Mexico City、墨西哥、16200
      • Puebla、墨西哥、72530
  • 大韩民国
      • Gyeonggi-do、大韩民国、410-769
      • Incheon、大韩民国、405-760
      • Seoul、大韩民国、110-744
      • Seoul、大韩民国、135-710
  • 奥地利
      • Innsbruck、奥地利、6020
      • Linz、奥地利、4010
      • Salzburg、奥地利、5020
      • Wien、奥地利、1160
      • Wien、奥地利、1220
  • 希腊
      • Larissa、希腊、41 110
      • Piraeus、希腊、18537
  • 意大利
    • Emilia-Romagna
      • Reggio Emilia、Emilia-Romagna、意大利、42100
    • Lazio
      • Roma、Lazio、意大利、00144
    • Puglia
      • Lecce、Puglia、意大利、73100
    • Toscana
      • Firenze、Toscana、意大利、50139
  • 斯洛文尼亚
      • Ljubljana、斯洛文尼亚、1000
  • 波兰
      • Krakow、波兰、30-501
      • Krakow、波兰、31-826
      • Warszawa、波兰、02-097
  • 英国
      • Bristol、英国、BS2 8ED
      • Colchester、英国、CO3 3NB
      • Glasgow、英国、G12 0YN
      • Leicester、英国、LE1 5WW
      • London、英国、W2 1NY
      • Manchester、英国、M20 4BX
      • Nottingham、英国、NG5 1PB
      • Rhyl、英国、LL18 5UJ
      • Sutton、英国、SM2 5PT
  • 荷兰
      • Apeldoorn、荷兰、7334 DZ
      • Eindhoven、荷兰、5623 EJ
      • Utrecht、荷兰、3527 CE
  • 西班牙
      • Barcelona、西班牙、08041
      • Jaen、西班牙、23007
      • Madrid、西班牙、28040
      • Murcia、西班牙、30120
      • Zaragoza、西班牙、50009
    • Las Palmas
      • Las Palmas de Gran Canaria、Las Palmas、西班牙、35016
    • Madrid
      • Leganes、Madrid、西班牙、28911

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:

  • Adult patients, ≥ 70 years of age.
  • Cancer of the colon or rectum.
  • Metastatic disease diagnosed ≤ 6 months before enrollment.
  • ≥ 1 measurable metastatic lesion.

Exclusion Criteria:

  • Adjuvant anti-vascular endothelial growth factor (VEGF) treatment.
  • Prior chemotherapeutic treatment for metastatic colorectal cancer.
  • Past or current history of other malignancies (with the exception of basal and squamous cell cancer of the skin, or in situ cancer of the cervix).
  • Clinically significant cardiovascular disease.
  • Current or recent daily use of aspirin (> 325 mg/day) or other non-steroidal anti-inflammatory drug (NSAID), or full dose anticoagulants.

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：Bevacizumab + capecitabine
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
药品：Bevacizumab
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Bevacizumab was supplied in single-use vials.
其他名称：
  • 阿瓦斯汀
药品：Capecitabine
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
其他名称：
  • 希罗达
有源比较器：Capecitabine
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
药品：Capecitabine
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
其他名称：
  • 希罗达

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
大体时间：Baseline to the end of the study (up to 5 years 8 months)
Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.
Baseline to the end of the study (up to 5 years 8 months)

次要结果测量

结果测量
措施说明
大体时间
Best Overall Response (BOR)
大体时间：Baseline to the end of the study (up to 5 years 8 months)
BOR was defined as the best response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], not evaluable [NE], or not assessed [NA]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.
Baseline to the end of the study (up to 5 years 8 months)
Duration of Response
大体时间：Baseline to the end of the study (up to 5 years 8 months)
Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs.
Baseline to the end of the study (up to 5 years 8 months)
Time to Response
大体时间：Baseline to the end of the study (up to 5 years 8 months)
Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. Participants who did not have a confirmed response were censored at the date of the last evaluable tumor assessment, or if that was unavailable, at the date of the first dose of study medication.
Baseline to the end of the study (up to 5 years 8 months)
Overall Survival
大体时间：Baseline to the end of the study (up to 5 years 8 months)
Overall survival was defined as the time in months from randomization to death from any cause.
Baseline to the end of the study (up to 5 years 8 months)
Eastern Cooperative Oncology Group (ECOG) Performance Status
大体时间：Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).
The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Reported is the percentage of participants in each of the 6 ECOG performance status categories.
Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).
Percentage of Participants Requiring Additional Treatment for Malignancy
大体时间：Baseline to the end of the study (up to 5 years 8 months)
Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period.
Baseline to the end of the study (up to 5 years 8 months)
Duration of Follow-up
大体时间：Baseline to the end of the study (up to 5 years 8 months)
Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival.
Baseline to the end of the study (up to 5 years 8 months)
AEs, Laboratory Parameters, Vital Signs
大体时间：Throughout study
Throughout study

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

Hoffmann-La Roche

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

2007年7月1日

初级完成 (实际的)

2013年3月1日

研究完成 (实际的)

2013年3月1日

研究注册日期

首次提交

2007年6月11日

首先提交符合 QC 标准的

2007年6月11日

首次发布 (估计)

2007年6月12日

研究记录更新

最后更新发布 (估计)

2015年1月8日

上次提交的符合 QC 标准的更新

2015年1月7日

最后验证

2015年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MO19286

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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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