VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00407654
First received: December 4, 2006
Last updated: July 22, 2015
Last verified: May 2013
Results First Received: March 27, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer
Intervention: Drug: aflibercept

  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
VEGF Trap IV Arm I

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

ziv-aflibercept: Given intravenously

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies


Participant Flow:   Overall Study
    VEGF Trap IV Arm I  
STARTED     75  
COMPLETED     75  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
Arm I

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

ziv-aflibercept: Given orally

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies


Baseline Measures
    Arm I  
Number of Participants  
[units: participants]
  75  
Age  
[units: years]
Median (Full Range)
  59  
  (39 to 80)  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     54  
>=65 years     21  
Gender  
[units: participants]
 
Female     29  
Male     46  
Region of Enrollment  
[units: participants]
 
Canada     49  
United States     26  



  Outcome Measures
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1.  Primary:   Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria)   [ Time Frame: Up to 6 years ]

2.  Primary:   Progression-free Survival (Bevacizumab- naïve Group)   [ Time Frame: 4 months ]

3.  Primary:   Progression-free Survival (Bevacizumab-treated Group)   [ Time Frame: 4 months ]

4.  Secondary:   Overall Survival (Bevacizumab-naïve Group)   [ Time Frame: 12 months ]

5.  Secondary:   Overall Survival (Prior Bevacizumab Treated Group)   [ Time Frame: 12 months ]

6.  Secondary:   Number of Participants With Response (Bevacizumab-naïve Group)   [ Time Frame: Up to 6 years ]

7.  Secondary:   Overall Survival (Bevacizumab-treated Group)   [ Time Frame: 6 months ]

8.  Secondary:   Overall Survival (Bevacizumab-treated Group)   [ Time Frame: 12 months ]

9.  Secondary:   Number of Participants With Response (Bevacizumab-treated Group)   [ Time Frame: Up to 6 years ]

10.  Secondary:   Time to Progression   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Objective Stable Disease Rate   [ Time Frame: Up to 6 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Malcolm Moore
Organization: Princess Margaret Cancer Centre
phone: 416-945-2263
e-mail: malcolm.moore@uhn.ca



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00407654     History of Changes
Other Study ID Numbers: NCI-2009-00176
PHL-050 ( Other Grant/Funding Number: N01CM62203 )
CDR0000518293 ( Other Grant/Funding Number: N01CM62203 )
N01CM62203 ( US NIH Grant/Contract Award Number )
Study First Received: December 4, 2006
Results First Received: March 27, 2015
Last Updated: July 22, 2015
Health Authority: United States: Food and Drug Administration