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Evaluating Panitumumab (ABX-EGF) in Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00111761
First received: May 25, 2005
Last updated: November 15, 2013
Last verified: November 2013
Results First Received: August 6, 2010  
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: Irinotecan
Biological: Panitumumab
Drug: 5-Fluorouracil
Drug: Leucovorin

  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
Participants were enrolled from 19 Jul 2002 through 20 April 2004

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
Panitumumab With FOLFIRI Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Panitumumab With IFL Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)

Participant Flow for 2 periods

Period 1:   Part 1
    Panitumumab With FOLFIRI     Panitumumab With IFL  
STARTED     0 [1]   19  
COMPLETED     0     14 [2]
NOT COMPLETED     0     5  
Physician Decision                 0                 1  
Death                 0                 2  
Other                 0                 1  
Withdrawal by Subject                 0                 1  
[1] This treatment group was not initiated until Part 2
[2] Completed through safety followup

Period 2:   Part 2
    Panitumumab With FOLFIRI     Panitumumab With IFL  
STARTED     24     0 [1]
COMPLETED     16     0  
NOT COMPLETED     8     0  
Adverse Event                 1                 0  
Physician Decision                 1                 0  
Death                 1                 0  
Disease progression                 3                 0  
Protocol-specified criteria                 1                 0  
Other                 1                 0  
[1] This treatment group was used in Part 1 only



  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
Panitumumab With IFL Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Panitumumab With FOLFIRI Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Total Total of all reporting groups

Baseline Measures
    Panitumumab With IFL     Panitumumab With FOLFIRI     Total  
Number of Participants  
[units: participants]
  19     24     43  
Age  
[units: Years]
Mean ± Standard Deviation
  56.6  ± 12.1     60.7  ± 15.0     58.9  ± 13.8  
Gender  
[units: Participants]
     
Female     3     10     13  
Male     16     14     30  
Race/Ethnicity, Customized  
[units: Participants]
     
Asian     1     1     2  
Black or African American     4     3     7  
Hispanic or Latino     1     2     3  
White or Caucasian     13     18     31  
Other     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2)   [ Time Frame: Until disease progression (median 47 weeks) ]

2.  Primary:   Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 1)   [ Time Frame: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first ]

3.  Secondary:   Number of Participants With an Objective Tumor Response (Part 2)   [ Time Frame: Until disease progression (median 47 weeks) ]

4.  Secondary:   Time to Disease Progression (Part 2)   [ Time Frame: From enrollment until death or diease progression. Maximum follow-up time was 16 months. ]

5.  Secondary:   Progression-free Survival Time (Part 2)   [ Time Frame: From enrollment until disease progression or death. Maximum follow-up time was 16 months. ]

6.  Secondary:   Survival Time (Part 2)   [ Time Frame: From enrollment until death. Maximum follow-up time was 16 months. ]

7.  Secondary:   Number of Participants Who Died (Part 2)   [ Time Frame: From enrollment until last contact. Maximum follow-up was 16 months. ]

8.  Secondary:   Number of Participants With Objective Tumor Response (Part 1)   [ Time Frame: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first ]

9.  Secondary:   Progression-free Survival Time (Part 1)   [ Time Frame: From enrollment until disease progression or death. Maximum follow-up time was 25 months. ]

10.  Secondary:   Time to Disease Progression (Part 1)   [ Time Frame: From enrollment until disease progression or death. Maximum follow-up time was 25 months. ]

11.  Secondary:   Survival Time (Part 1)   [ Time Frame: From enrollment until death. Maximum follow-up time was 25 months. ]

12.  Secondary:   Time to Treatment Failure (Part 1)   [ Time Frame: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first ]

13.  Secondary:   Time to Initial Objective Tumor Response (Part 1)   [ Time Frame: Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first ]


  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
No text entered.


  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: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00111761     History of Changes
Obsolete Identifiers: NCT00047151
Other Study ID Numbers: 20025409
Study First Received: May 25, 2005
Results First Received: August 6, 2010
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration