A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01159171
First received: July 7, 2010
Last updated: July 24, 2014
Last verified: July 2014
Results First Received: May 20, 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: capecitabine [Xeloda]
Drug: oxaliplatin

  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
No text entered.

Reporting Groups
  Description
Bevacizumab + Oxaliplatin + Capecitabine Participants received bevacizumab 5 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1 and 15; oxaliplatin 40 mg per square meter (mg/m^2) IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.

Participant Flow:   Overall Study
    Bevacizumab + Oxaliplatin + Capecitabine  
STARTED     50  
COMPLETED     0  
NOT COMPLETED     50  
Adverse Event                 11  
Progression of Disease                 28  
Protocol Violation                 1  
Need for Surgery                 5  
Medical Decision                 4  
Death                 1  



  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.
Safety population: all participants who received at least one dose of one study medication.

Reporting Groups
  Description
Bevacizumab + Oxaliplatin + Capecitabine Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.

Baseline Measures
    Bevacizumab + Oxaliplatin + Capecitabine  
Number of Participants  
[units: participants]
  49  
Age  
[units: years]
Mean ± Standard Deviation
  59.08  ± 9.62  
Gender  
[units: participants]
 
Female     25  
Male     24  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Objective Response (OR)   [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]

2.  Primary:   Percentage of Participants by Best Overall Response   [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]

3.  Secondary:   Duration of Response - Percentage of Participants With an Event by 24 Months   [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]

4.  Secondary:   Duration of Response   [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]

5.  Secondary:   Duration of Stable Disease - Percentage of Participants With an Event by 24 Months   [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]

6.  Secondary:   Duration of Stable Disease   [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ]

7.  Secondary:   Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months   [ Time Frame: Baseline, every month to end of treatment (up to 24 months) ]

8.  Secondary:   Time to Treatment Failure   [ Time Frame: Baseline, monthly to end of study (up to 24 months) ]

9.  Secondary:   Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months   [ Time Frame: Baseline, monthly to end of study (up to 24 months) ]

10.  Secondary:   Time to Progression   [ Time Frame: Baseline, monthly to end of study (up to 24 months) ]

11.  Secondary:   Overall Survival (OS) - Percentage of Participants With an Event by 24 Months   [ Time Frame: Baseline, monthly to end of study (up to 24 months) ]

12.  Secondary:   Overall Survival   [ Time Frame: Baseline, monthly to end of study (up to 24 months) ]


  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: NCT01159171     History of Changes
Other Study ID Numbers: ML18523
Study First Received: July 7, 2010
Results First Received: May 20, 2014
Last Updated: July 24, 2014
Health Authority: Italy: Italian Medicines Agency (AIFA)