Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00113763
First received: June 10, 2005
Last updated: July 15, 2014
Last verified: July 2014
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
Conditions: Colorectal Cancer
Metastases
Interventions: Other: Best supportive care
Drug: Panitumumab

  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 16 January 2004 through 16 March 2005. Data are up until the data cutoff of 15 March 2007.

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
Panitumumab Plus BSC Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
BSC Alone Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.

Participant Flow:   Overall Study
    Panitumumab Plus BSC     BSC Alone  
STARTED     231     232  
Received Study Drug     229     0  
COMPLETED     158 [1]   206 [1]
NOT COMPLETED     73     26  
Adverse Event                 5                 2  
Disease Progression                 28                 14  
Lost to Follow-up                 10                 0  
Withdrawal by Subject                 1                 4  
Not specified                 27                 6  
Non-compliance                 1                 0  
Ongoing                 1                 0  
[1] Defined as participants who completed safety follow-up visit or who died.



  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 Plus BSC Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
BSC Alone Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
Total Total of all reporting groups

Baseline Measures
    Panitumumab Plus BSC     BSC Alone     Total  
Number of Participants  
[units: participants]
  231     232     463  
Age  
[units: years]
Mean ± Standard Deviation
  61.2  ± 10.3     61.4  ± 10.8     61.3  ± 10.5  
Gender  
[units: participants]
     
Female     85     84     169  
Male     146     148     294  
Race/Ethnicity, Customized  
[units: participants]
     
Japanese     0     1     1  
Aborigine     0     0     0  
Other     0     0     0  
American Indian or Alaska Native     0     0     0  
Asian     0     2     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     0     1  
White or Caucasian     229     228     457  
Hispanic or Latino     1     1     2  
Region of Enrollment [1]
[units: participants]
     
Central and Eastern Europe     20     19     39  
Western Europe     178     180     358  
Rest of World     33     33     66  
Eastern Cooperative Oncology Group (ECOG) performance status [2]
[units: participants]
     
0 or 1     200     202     402  
2     31     30     61  
[1] Central and Eastern Europe includes the Czech Republic, Greece, Hungary, and the Slovak Republic. Rest of World includes Australia, Canada and New Zealand. Western Europe includes Austria, Belgium, France, Germany, Italy, Portugal, Spain, Switzerland, and the Netherlands.
[2] Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.



  Outcome Measures
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1.  Primary:   Progression-free Survival Time   [ Time Frame: From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group. ]

2.  Secondary:   Overall Survival   [ Time Frame: From randomization until the data cut-off date for overall survival of 15 March 2006. The median actual follow-up time was 30 weeks for the panitumumab plus BSC group and 31 weeks for the BSC alone group. ]

3.  Secondary:   Objective Tumor Response   [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]

4.  Secondary:   Duration of Response   [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]

5.  Secondary:   Time to Response   [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]

6.  Secondary:   Time to Disease Progression   [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]

7.  Secondary:   Time to Treatment Failure   [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]

8.  Secondary:   Duration of Stable Disease   [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group. ]

9.  Post-Hoc:   Progression-free Survival Time (Wild-type KRAS)   [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with wild-type KRAS was 36.8 weeks in the panitumumab plus BSC group and 35.7 weeks in the BSC alone group. ]

10.  Post-Hoc:   Progression-free Survival Time (Mutant KRAS)   [ Time Frame: From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with mutant KRAS was 24.4 weeks in the panitumumab plus BSC group and 23.9 weeks in the BSC alone group. ]


  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 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:
Publications automatically indexed to this study:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00113763     History of Changes
Other Study ID Numbers: 20020408
Study First Received: June 10, 2005
Results First Received: August 6, 2010
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration