A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01135498
First received: June 1, 2010
Last updated: January 22, 2015
Last verified: January 2015
Results First Received: November 5, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: bevacizumab [Avastin]
Drug: eloxatin
Drug: capecitabine [Xeloda]
Drug: erlotinib [Tarceva]

  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+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib

Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2, tablet, orally (PO), every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.

Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.


Participant Flow:   Overall Study
    Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib  
STARTED     90  
COMPLETED     0  
NOT COMPLETED     90  
Adverse Event                 20  
Progressive disease                 38  
Investigator judgement                 25  
Withdrawal by Subject                 4  
Death                 1  
Ongoing at time of analysis                 2  



  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 (ITT) population: all enrolled participants.

Reporting Groups
  Description
Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib

Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.

Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression.


Baseline Measures
    Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib  
Number of Participants  
[units: participants]
  90  
Age  
[units: years]
Mean (Standard Deviation)
  59.23  (8.18)  
Gender  
[units: participants]
 
Female     29  
Male     61  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Disease Progression or Death   [ Time Frame: Start of study to approximately 4 years ]

2.  Primary:   Progression-Free Survival   [ Time Frame: From study start up to approximately 4 years ]

3.  Secondary:   Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])   [ Time Frame: From study start up to approximately 4 years ]

4.  Secondary:   Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])   [ Time Frame: From study start up to approximately 4 years ]

5.  Secondary:   Percentage of Participants Who Died   [ Time Frame: From study start up to approximately 4 years ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: From study start up to approximately 4 years ]


  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-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01135498     History of Changes
Other Study ID Numbers: ML19875
Study First Received: June 1, 2010
Results First Received: November 5, 2014
Last Updated: January 22, 2015
Health Authority: Spain: Ministry of Health and Consumption