Erbitux (Cetuximab) Given Alone to Patients With EGFR-Negative Metastatic Colon or Rectal Cancer That is Refractory to Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00083720
First received: May 28, 2004
Last updated: May 19, 2011
Last verified: May 2011
Results First Received: April 16, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Colorectal Neoplasms
Metastases
Neoplasm
Intervention: Biological: cetuximab

  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
A total of 87 patients were enrolled between 22 Oct 2004 and 20 Aug 2007 at nine sites in the USA and four sites in Canada.

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
Cetuximab Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Participant Flow:   Overall Study
    Cetuximab  
STARTED     85 [1]
COMPLETED     85 [2]
NOT COMPLETED     0  
[1] Patients analyzed for efficacy who met the epidermal growth factor receptor (EGFR) negative criteria
[2] Two patients died prior to receiving cetuximab.



  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
Cetuximab Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes

Baseline Measures
    Cetuximab  
Number of Participants  
[units: participants]
  85  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     42  
>=65 years     43  
Age  
[units: years]
Mean ± Standard Deviation
  64.2  ± 11.41  
Gender  
[units: participants]
 
Female     26  
Male     59  
Region of Enrollment  
[units: participants]
 
United States     20  
Canada     65  



  Outcome Measures
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1.  Primary:   Percentage of Participants With an Overall Resonse   [ Time Frame: Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progressive disease (PD) or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation. ]

2.  Primary:   Number of Participants With Adverse Events   [ Time Frame: An adverse event (AE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab. ]

3.  Primary:   Number of Participants With Serious Adverse Events   [ Time Frame: A serious adverse event (SAE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab. ]

4.  Secondary:   Percentage of Participants With Disease Control (CR, PR, or SD)   [ Time Frame: Tumor evaluations were performed at a minimum of every 6 weeks while on cetuximab therapy. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response. ]

5.  Secondary:   Duration of Response   [ Time Frame: The duration of response was measured from the date of response to the first date of PD (range 2 to 7 months). ]

6.  Secondary:   Time to Progression   [ Time Frame: Patients with PD after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine (range: 1-3 months). ]

7.  Secondary:   Overall Survival   [ Time Frame: Survival information was collected every 3 months after completion of therapy and/or follow-up up to 24 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: Chief Medical Officer
Organization: ImClone, LLC
e-mail: ClinicalTrials@imclone.com


No publications provided


Responsible Party: Chief Medical Officer, ImClone LLC
ClinicalTrials.gov Identifier: NCT00083720     History of Changes
Other Study ID Numbers: CP02-0451
Study First Received: May 28, 2004
Results First Received: April 16, 2009
Last Updated: May 19, 2011
Health Authority: United States: Food and Drug Administration
Canada: Ethics Review Committee
Canada: Health Canada