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: May 28, 2014
Last verified: May 2014
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


  Baseline Characteristics
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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). ]

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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: May 28, 2014
Health Authority: Hungary: Ministry of Health