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A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01181609
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Colorectal Cancer
Intervention: Drug: bevacizumab [Avastin]

  Participant Flow

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 + Chemotherapy Participants received bevacizumab 2.5 milligrams per kilogram (mg/kg) intravenously (IV) per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.

Participant Flow:   Overall Study
    Bevacizumab + Chemotherapy
STARTED   54 
COMPLETED   1 
NOT COMPLETED   53 
Adverse Event                1 
Withdrawal by Subject                1 
Lost to Follow-up                1 
Death                50 



  Baseline Characteristics

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: included participants who received at least 1 dose of treatment.

Reporting Groups
  Description
Bevacizumab + Chemotherapy Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.

Baseline Measures
   Bevacizumab + Chemotherapy 
Overall Participants Analyzed 
[Units: Participants]
 53 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.2  (11.6) 
Gender 
[Units: Participants]
 
Female   18 
Male   35 


  Outcome Measures

1.  Primary:   Percentage of Participants Achieving Overall Disease Control (ODC)   [ Time Frame: Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up) ]

2.  Secondary:   Percentage of Participants Achieving a Best Overall Response of CR or PR   [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ]

3.  Secondary:   Progression-Free Survival (PFS) - Percentage of Participants With an Event   [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ]

4.  Secondary:   PFS - Time to Event   [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ]

5.  Secondary:   Duration of Response   [ Time Frame: Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up) ]

6.  Secondary:   Duration of Overall Disease Control   [ Time Frame: Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up) ]

7.  Secondary:   Overall Survival (OS) - Percentage of Participants With an Event   [ Time Frame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) ]

8.  Secondary:   OS - Time to Event   [ Time Frame: Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up) ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01181609     History of Changes
Other Study ID Numbers: ML18559
First Submitted: July 30, 2010
First Posted: August 13, 2010
Results First Submitted: June 4, 2014
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014