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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00484939
First received: June 11, 2007
Last updated: January 7, 2015
Last verified: January 2015
Results First Received: March 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: Bevacizumab
Drug: Capecitabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.
Capecitabine Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.

Participant Flow:   Overall Study
    Bevacizumab + Capecitabine     Capecitabine  
STARTED     140     140  
COMPLETED     0     0  
NOT COMPLETED     140     140  
Death                 9                 13  
Adverse Event                 22                 12  
Patient Withdrew Consent                 19                 10  
Protocol Violation                 3                 3  
Lost to Follow-up                 0                 3  
Discretion of Investigator or Sponsor                 7                 3  
Disease progression                 67                 88  
Screen Failure                 2                 2  
Reason Not Specified                 11                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population: All participants randomized into the study.

Reporting Groups
  Description
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.
Capecitabine Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Total Total of all reporting groups

Baseline Measures
    Bevacizumab + Capecitabine     Capecitabine     Total  
Number of Participants  
[units: participants]
  140     140     280  
Age  
[units: years]
Mean (Standard Deviation)
  76.1  (4.18)     76.5  (3.91)     76.3  (4.04)  
Gender  
[units: participants]
     
Female     56     56     112  
Male     84     84     168  



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ]

2.  Secondary:   Best Overall Response (BOR)   [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ]

3.  Secondary:   Duration of Response   [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ]

4.  Secondary:   Time to Response   [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ]

5.  Secondary:   Overall Survival   [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ]

6.  Secondary:   Eastern Cooperative Oncology Group (ECOG) Performance Status   [ Time Frame: Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months). ]
  Hide Outcome Measure 6

Measure Type Secondary
Measure Title Eastern Cooperative Oncology Group (ECOG) Performance Status
Measure Description 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.
Time Frame Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population: All participants randomized into the study.

Reporting Groups
  Description
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.
Capecitabine Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.

Measured Values
    Bevacizumab + Capecitabine     Capecitabine  
Number of Participants Analyzed  
[units: participants]
  140     140  
Eastern Cooperative Oncology Group (ECOG) Performance Status  
[units: Percentage¬†of¬†participants]
   
Week 7 ECOG = 0 (n=117,110)     50.4     34.5  
Week 7 ECOG = 1     47.0     58.2  
Week 7 ECOG = 2     1.7     5.5  
Week 7 ECOG = 3     0.9     1.8  
Week 7 ECOG = 4     0.0     0.0  
Week 7 ECOG = 5     0.0     0.0  
Week 16 ECOG = 0 (n=88,77)     50.0     36.4  
Week 16 ECOG = 1     45.5     51.9  
Week 16 ECOG = 2     3.4     11.7  
Week 16 ECOG = 3     1.1     0.0  
Week 16 ECOG = 4     0.0     0.0  
Week 16 ECOG = 5     0.0     0.0  
Week 25 ECOG = 0 (n=66,42)     43.9     45.2  
Week 25 ECOG = 1     48.5     45.2  
Week 25 ECOG = 2     6.1     9.5  
Week 25 ECOG = 3     1.5     0.0  
Week 25 ECOG = 4     0.0     0.0  
Week 25 ECOG = 5     0.0     0.0  
Week 34 ECOG = 0 (n=48,24)     39.6     33.3  
Week 34 ECOG = 1     58.3     58.3  
Week 34 ECOG = 2     0.0     8.3  
Week 34 ECOG = 3     2.1     0.0  
Week 34 ECOG = 4     0.0     0.0  
Week 34 ECOG = 5     0.0     0.0  
Safety Follow-up ECOG = 0 (n=89,82)     33.7     32.9  
Safety Follow-up ECOG = 1     47.2     45.1  
Safety Follow-up ECOG = 2     12.4     14.6  
Safety Follow-up ECOG = 3     6.7     4.9  
Safety Follow-up ECOG = 4     0.0     1.2  
Safety Follow-up ECOG = 5     0.0     1.2  

No statistical analysis provided for Eastern Cooperative Oncology Group (ECOG) Performance Status



7.  Secondary:   Percentage of Participants Requiring Additional Treatment for Malignancy   [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ]

8.  Secondary:   Duration of Follow-up   [ Time Frame: Baseline to the end of the study (up to 5 years 8 months) ]

9.  Secondary:   AEs, Laboratory Parameters, Vital Signs   [ Time Frame: Throughout study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00484939     History of Changes
Other Study ID Numbers: MO19286
Study First Received: June 11, 2007
Results First Received: March 7, 2014
Last Updated: January 7, 2015
Health Authority: Hungary: Ministry of Health