FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01226719
First received: October 15, 2010
Last updated: May 7, 2015
Last verified: May 2015
Results First Received: February 26, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: Panitumumab
Drug: Oxaliplatin
Drug: Irinotecan
Drug: Leucovorin
Drug: 5-Fluorouracil

  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
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
FOLFOXIRI+Panitumumab Regimen

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil

Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks

Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks

Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks

Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks

5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks


Participant Flow:   Overall Study
    FOLFOXIRI+Panitumumab Regimen  
STARTED     15  
COMPLETED     2 [1]
NOT COMPLETED     13  
[1] Completed = patient is surgical candidate, underwent resection, received treatment to week 24.



  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.
All patients on study

Reporting Groups
  Description
FOLFOXIRI+Panitumumab Regimen

All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:

  • Panitumumab
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • 5-Fluorouracil

Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks

Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks

Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks

Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks

5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks


Baseline Measures
    FOLFOXIRI+Panitumumab Regimen  
Number of Participants  
[units: participants]
  15  
Age  
[units: years]
Median (Full Range)
  55    (39 to 70)  
Gender  
[units: participants]
 
Female     2  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: 18 months ]

2.  Secondary:   R0 Resection Rate   [ Time Frame: 18 months ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: 18 months ]

4.  Secondary:   To Determine the Acute Toxicity Produced by This Regimen.   [ Time Frame: 18 months ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: 18 months ]


  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: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


No publications provided


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01226719     History of Changes
Other Study ID Numbers: SCRI GI 134
Study First Received: October 15, 2010
Results First Received: February 26, 2015
Last Updated: May 7, 2015
Health Authority: United States: Food and Drug Administration