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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;   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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.  


  Serious 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.

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.

Serious Adverse Events
    Bevacizumab + Capecitabine   Capecitabine
Total, Serious Adverse Events     
# participants affected / at risk   40/134 (29.85%)   42/136 (30.88%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Neutropenia † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Cardiac disorders     
Cardiac arrest † 1     
# participants affected / at risk   1/134 (0.75%)   2/136 (1.47%) 
Angina pectoris † 1     
# participants affected / at risk   1/134 (0.75%)   1/136 (0.74%) 
Myocardial infarction † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Myocardial ischaemia † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Cardiac failure † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Eye disorders     
Amaurosis fugax † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   3/134 (2.24%)   4/136 (2.94%) 
Intestinal obstruction † 1     
# participants affected / at risk   3/134 (2.24%)   4/136 (2.94%) 
Vomiting † 1     
# participants affected / at risk   2/134 (1.49%)   2/136 (1.47%) 
Abdominal discomfort † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Haematochezia † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Inguinal hernia † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Nausea † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Small intestinal obstruction † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Diarrhoea † 1     
# participants affected / at risk   0/134 (0.00%)   4/136 (2.94%) 
Ascites † 1     
# participants affected / at risk   0/134 (0.00%)   3/136 (2.21%) 
Colonic obstruction † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Mechanical ileus † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Upper gastrointestinal haemorrhage † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
General disorders     
Pyrexia † 1     
# participants affected / at risk   3/134 (2.24%)   2/136 (1.47%) 
General physical health deterioration † 1     
# participants affected / at risk   1/134 (0.75%)   2/136 (1.47%) 
Pain † 1     
# participants affected / at risk   1/134 (0.75%)   1/136 (0.74%) 
Death † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Oedema † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Asthenia † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Fatigue † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Hepatobiliary disorders     
Jaundice † 1     
# participants affected / at risk   0/134 (0.00%)   2/136 (1.47%) 
Hepatic failure † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Hepatitis acute † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Infections and infestations     
Pneumonia † 1     
# participants affected / at risk   3/134 (2.24%)   1/136 (0.74%) 
Bronchitis † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Escherichia urinary tract infection † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Lower respiratory tract infection † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Pneumonia bacterial † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Pulmonary sepsis † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Urosepsis † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Cellulitis gangrenous † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Gastroenteritis † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Sepsis † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Injury, poisoning and procedural complications     
Excoriation † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Impacted fracture † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Patella fracture † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Spinal compression fracture † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Metabolism and nutrition disorders     
Dehydration † 1     
# participants affected / at risk   1/134 (0.75%)   1/136 (0.74%) 
Decreased appetite † 1     
# participants affected / at risk   0/134 (0.00%)   2/136 (1.47%) 
Musculoskeletal and connective tissue disorders     
Groin pain † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Neck pain † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic neoplasm † 1     
# participants affected / at risk   1/134 (0.75%)   1/136 (0.74%) 
Metastases to lung † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Nervous system disorders     
Transient ischaemic attack † 1     
# participants affected / at risk   1/134 (0.75%)   1/136 (0.74%) 
Amnesia † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Cerebral ischaemia † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Lethargy † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Somnolence † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Renal and urinary disorders     
Calculus ureteric † 1     
# participants affected / at risk   1/134 (0.75%)   1/136 (0.74%) 
Renal failure † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Reproductive system and breast disorders     
Female genital tract fistula † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism † 1     
# participants affected / at risk   8/134 (5.97%)   2/136 (1.47%) 
Pleural effusion † 1     
# participants affected / at risk   1/134 (0.75%)   1/136 (0.74%) 
Dyspnoea † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Skin and subcutaneous tissue disorders     
Rash macular † 1     
# participants affected / at risk   1/134 (0.75%)   0/136 (0.00%) 
Surgical and medical procedures     
Bone operation † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   2/134 (1.49%)   1/136 (0.74%) 
Thrombosis † 1     
# participants affected / at risk   2/134 (1.49%)   0/136 (0.00%) 
Deep vein thrombosis † 1     
# participants affected / at risk   0/134 (0.00%)   3/136 (2.21%) 
Circulatory collapse † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Peripheral artery thrombosis † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Vena cava thrombosis † 1     
# participants affected / at risk   0/134 (0.00%)   1/136 (0.74%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.1)




  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
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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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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