Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00083616
First received: May 26, 2004
Last updated: December 10, 2013
Last verified: December 2013
Results First Received: August 6, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Colorectal Cancer
Metastatic Cancer
Intervention: Biological: Panitumumab

  Participant Flow
  Hide Participant Flow

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 1 March 2004 through 19 Jul 2006. Patient disposition is reported up until the data cut-off date of 22 December 2006. Completed study is defined as participants who either died on study or completed the safety follow-up visit (30 days after the last dose of panitumumab).

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 (ABX-EGF) Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.

Participant Flow:   Overall Study
    Panitumumab (ABX-EGF)  
STARTED     185  
Received Study Medication     182  
COMPLETED     154 [1]
NOT COMPLETED     31  
Disease Progression                 16  
Lost to Follow-up                 1  
Physician Decision                 2  
Withdrawal by Subject                 3  
Ineligibility determined                 2  
Non-compliance                 1  
Other                 6  
[1] Completed safety followup or died on study as of the data cut-off date of 22 December 2006



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
Panitumumab Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.

Baseline Measures
    Panitumumab  
Number of Participants  
[units: participants]
  185  
Age  
[units: Years]
Mean ± Standard Deviation
  59.6  ± 10.6  
Gender  
[units: Participants]
 
Female     85  
Male     100  
Race/Ethnicity, Customized  
[units: Participants]
 
American Indian or Alaska Native     0  
Asian     4  
Black or African American     15  
Hispanic or Latino     19  
Japanese     0  
Native Hawaiian or Other Pacific Islander     1  
White or Caucasian     144  
Other     2  
Aborigine     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Objective Tumor Response Through Week 16   [ Time Frame: 16 weeks ]

2.  Primary:   Duration of Response   [ Time Frame: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks. ]

3.  Secondary:   Number of Participants With Objective Tumor Response Throughout Study   [ Time Frame: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks. ]

4.  Secondary:   Time to Response   [ Time Frame: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks. ]

5.  Secondary:   Progression-free Survival Time   [ Time Frame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. ]

6.  Secondary:   Time to Disease Progression   [ Time Frame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. ]

7.  Secondary:   Time to Treatment Failure   [ Time Frame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. ]

8.  Secondary:   Duration of Stable Disease   [ Time Frame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. ]

9.  Secondary:   Overall Survival   [ Time Frame: Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


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


No publications provided


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00083616     History of Changes
Obsolete Identifiers: NCT00087243
Other Study ID Numbers: 20030167
Study First Received: May 26, 2004
Results First Received: August 6, 2010
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration