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Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00842257
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Amgen
Information provided by (Responsible Party):
David Patrick Ryan, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Colorectal Cancer
Intervention: Drug: panitumumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects identified by their treating oncologist in the Gastrointestinal Cancer Clinics at Massachusetts General Hospital and Dana-Farber Cancer Institute, all therapy options are discussed (including participation in this trial).

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 Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.

Participant Flow:   Overall Study
    Panitumumab
STARTED   20 
COMPLETED   19 
NOT COMPLETED   1 
Adverse Event                1 



  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 Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.

Baseline Measures
   Panitumumab 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Median (Full Range)
 
Participants Analyzed   20 
   54.5 
 (39 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   20 
Female      10  50.0% 
Male      10  50.0% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   
Participants Analyzed   20 
United States   20 
ECOG PS [1] 
[Units: Participants]
Count of Participants
 
 
Participants Analyzed   20 
 4 
 
Participants Analyzed   20 
 14 
 
Participants Analyzed   20 
 2 
[1]

Eastern Cooperative Oncology Group Performance Status. 0 Fully active, able to carry on all pre-disease performance without restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
  3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
  4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
  5. Dead
Primary tumor 
[Units: Participants]
Count of Participants
 
Colon   
Participants Analyzed   20 
Colon   17 
Rectal   
Participants Analyzed   20 
Rectal   3 
Metastatic sites 
[Units: Participants]
 
Liver   
Participants Analyzed   20 
Liver   15 
Lung   
Participants Analyzed   20 
Lung   11 
Lymph Nodes   
Participants Analyzed   20 
Lymph Nodes   9 
Prior therapy 
[Units: Participants]
 
Cetuximab   
Participants Analyzed   20 
Cetuximab   20 
Flouropyrimidine   
Participants Analyzed   20 
Flouropyrimidine   20 
Oxaliplatin   
Participants Analyzed   20 
Oxaliplatin   19 
Irinotecan   
Participants Analyzed   20 
Irinotecan   18 
Bevacizumab   
Participants Analyzed   20 
Bevacizumab   17 


  Outcome Measures

1.  Primary:   Response Rate of Single Agent Panitumumab Among Patients With KRAS Wild-type Colorectal Cancer Previously Treated With Cetuximab.   [ Time Frame: 3 years ]

2.  Secondary:   Median Progression Free Survival (PFS)   [ Time Frame: 3 years ]

3.  Secondary:   Median Overall Survival   [ Time Frame: 3 years ]

4.  Secondary:   Disease Control Rate as Defined by RECIST Criteria   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. David Patrick Ryan, Chief, Hem/Onc
Organization: Massachusetts General Hospital
phone: 617-974-4545
e-mail: DPRYAN@mgh.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David Patrick Ryan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00842257     History of Changes
Other Study ID Numbers: 08-287
20070602 ( Other Identifier: Amgen )
First Submitted: February 10, 2009
First Posted: February 12, 2009
Results First Submitted: February 10, 2017
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017