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
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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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). ]

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
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Time Frame No text entered.
Additional Description Safety population: All participants who had at least 1 dose of study medication.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    Bevacizumab + Capecitabine     Capecitabine  
Total, other (not including serious) adverse events      
# participants affected / at risk     129/134     130/136  
Blood and lymphatic system disorders      
Neutropenia † 1    
# participants affected / at risk     7/134 (5.22%)     2/136 (1.47%)  
Gastrointestinal disorders      
Diarrhoea † 1    
# participants affected / at risk     54/134 (40.30%)     48/136 (35.29%)  
Nausea † 1    
# participants affected / at risk     32/134 (23.88%)     37/136 (27.21%)  
Abdominal pain † 1    
# participants affected / at risk     31/134 (23.13%)     21/136 (15.44%)  
Vomiting † 1    
# participants affected / at risk     28/134 (20.90%)     16/136 (11.76%)  
Constipation † 1    
# participants affected / at risk     25/134 (18.66%)     19/136 (13.97%)  
Stomatitis † 1    
# participants affected / at risk     14/134 (10.45%)     14/136 (10.29%)  
Abdominal pain upper † 1    
# participants affected / at risk     11/134 (8.21%)     5/136 (3.68%)  
Dyspepsia † 1    
# participants affected / at risk     9/134 (6.72%)     4/136 (2.94%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     32/134 (23.88%)     37/136 (27.21%)  
Asthenia † 1    
# participants affected / at risk     30/134 (22.39%)     22/136 (16.18%)  
Pyrexia † 1    
# participants affected / at risk     24/134 (17.91%)     16/136 (11.76%)  
Mucosal inflammation † 1    
# participants affected / at risk     20/134 (14.93%)     11/136 (8.09%)  
Oedema peripheral † 1    
# participants affected / at risk     11/134 (8.21%)     17/136 (12.50%)  
Pain † 1    
# participants affected / at risk     11/134 (8.21%)     6/136 (4.41%)  
Metabolism and nutrition disorders      
Decreased Appetite † 1    
# participants affected / at risk     38/134 (28.36%)     31/136 (22.79%)  
Musculoskeletal and connective tissue disorders      
Back pain † 1    
# participants affected / at risk     13/134 (9.70%)     11/136 (8.09%)  
Arthralgia † 1    
# participants affected / at risk     12/134 (8.96%)     4/136 (2.94%)  
Pain in extremity † 1    
# participants affected / at risk     11/134 (8.21%)     5/136 (3.68%)  
Musculoskeletal pain † 1    
# participants affected / at risk     10/134 (7.46%)     4/136 (2.94%)  
Nervous system disorders      
Lethargy † 1    
# participants affected / at risk     12/134 (8.96%)     15/136 (11.03%)  
Headache † 1    
# participants affected / at risk     10/134 (7.46%)     5/136 (3.68%)  
Dizziness † 1    
# participants affected / at risk     9/134 (6.72%)     17/136 (12.50%)  
Dysgeusia † 1    
# participants affected / at risk     8/134 (5.97%)     6/136 (4.41%)  
Paraesthesia † 1    
# participants affected / at risk     8/134 (5.97%)     1/136 (0.74%)  
Psychiatric disorders      
Insomnia † 1    
# participants affected / at risk     7/134 (5.22%)     7/136 (5.15%)  
Renal and urinary disorders      
Proteinuria † 1    
# participants affected / at risk     10/134 (7.46%)     1/136 (0.74%)  
Respiratory, thoracic and mediastinal disorders      
Epistaxis † 1    
# participants affected / at risk     23/134 (17.16%)     5/136 (3.68%)  
Cough † 1    
# participants affected / at risk     15/134 (11.19%)     12/136 (8.82%)  
Dyspnoea † 1    
# participants affected / at risk     12/134 (8.96%)     13/136 (9.56%)  
Pulmonary embolism † 1    
# participants affected / at risk     9/134 (6.72%)     2/136 (1.47%)  
Rhinorrhoea † 1    
# participants affected / at risk     8/134 (5.97%)     1/136 (0.74%)  
Skin and subcutaneous tissue disorders      
Palmar-Plantar erythrodysaesthesia syndrome † 1    
# participants affected / at risk     66/134 (49.25%)     54/136 (39.71%)  
Skin hyperpigmentation † 1    
# participants affected / at risk     11/134 (8.21%)     2/136 (1.47%)  
Dry skin † 1    
# participants affected / at risk     8/134 (5.97%)     4/136 (2.94%)  
Rash † 1    
# participants affected / at risk     6/134 (4.48%)     12/136 (8.82%)  
Vascular disorders      
Hypertension † 1    
# participants affected / at risk     22/134 (16.42%)     6/136 (4.41%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.1)



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