A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00700102
First received: June 17, 2008
Last updated: July 2, 2015
Last verified: July 2015
Results First Received: July 2, 2015  
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: Chemotherapy
Drug: Bevacizumab

  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
This study enrolled 820 patients at 220 sites located in 15 countries in Europe and Saudi Arabia. Study AIO KRK 0504 enrolled 261 patients, and 559 patients subsequently enrolled in Study ML18147 when the study was transferred to Hoffmann LaRoche (in 2008).

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
Chemotherapy

Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal

Chemotherapy: As prescribed

Chemotherapy + Bevacizumab

Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal

Chemotherapy: As prescribed

Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.


Participant Flow:   Overall Study
    Chemotherapy     Chemotherapy + Bevacizumab  
STARTED     411     409  
Intention to Treat     410     409  
Received at Least One Dose     407     403  
COMPLETED     9     14  
NOT COMPLETED     402     395  
Died                 394                 385  
Lost to Follow-up                 8                 10  



  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.
No text entered.

Reporting Groups
  Description
Chemotherapy

Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal

Chemotherapy: As prescribed

Chemotherapy + Bevacizumab

Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal

Chemotherapy: As prescribed

Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.

Total Total of all reporting groups

Baseline Measures
    Chemotherapy     Chemotherapy + Bevacizumab     Total  
Number of Participants  
[units: participants]
  411     409     820  
Age  
[units: years]
Mean (Standard Deviation)
  61.9  (9.55)     62.1  (9.78)     62.0  (9.66)  
Gender  
[units: participants]
     
Female     152     142     294  
Male     259     267     526  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival: Time From Randomization to Death From Any Cause   [ Time Frame: within 6.5 years ]

2.  Secondary:   Overall Survival: Months From Time of First Line Therapy   [ Time Frame: within approximately 9.6 years ]

3.  Secondary:   Participants With Progression Free Survival Event   [ Time Frame: within 6.5 years ]

4.  Secondary:   Progression Free Survival: Time to Event   [ Time Frame: within 6.5 years ]

5.  Secondary:   Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria   [ Time Frame: within 6.5 years ]

6.  Secondary:   Response Rate: Participants With Response Status Based on RECIST Criteria   [ Time Frame: within 6.5 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
Patients in the study who were randomized to receive bevacizumab could continue to receive bevacizumab following discontinuation of chemotherapy, thereby minimizing any potential bias introduced by differential follow-up time in the treatment arms.


  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
e-mail: genentech@druginfo.com


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00700102     History of Changes
Other Study ID Numbers: ML18147, 2006-004634-32
Study First Received: June 17, 2008
Results First Received: July 2, 2015
Last Updated: July 2, 2015
Health Authority: Germany: Ethics Commission