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S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00096031
First received: November 9, 2004
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
Results First Received: April 4, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Esophageal Cancer
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
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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
Cetuximab 250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.

Participant Flow:   Overall Study
    Cetuximab
STARTED   63 
Eligible   57 
Eligible and Began Protocol Therapy   55 
COMPLETED   0 
NOT COMPLETED   63 
Adverse Event                3 
Lack of Efficacy                42 
Death                4 
Withdrawal by Subject                1 
Ineligible                8 
Not protocol specified                5 



  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.
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Reporting Groups
  Description
Cetuximab 250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.

Baseline Measures
   Cetuximab 
Overall Participants Analyzed 
[Units: Participants]
 		 55 
Age 
[Units: Years]
Median (Full Range) 		 61.2 
 (30.7 to 88.5) 
Gender 
[Units: Participants]
 		 
Female   6 
Male   49 
Ethnicity (NIH/OMB) 
[Units: Participants]
 		 
Hispanic or Latino   0 
Not Hispanic or Latino   49 
Unknown or Not Reported   6 
Race (NIH/OMB) 
[Units: Participants]
 		 
American Indian or Alaska Native   1 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   54 
More than one race   0 
Unknown or Not Reported   0 


  Outcome Measures
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1.  Primary:   Overall Survival at 6 Months   [ Time Frame: every 3 weeks while on treatment, then every 3 months ]
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2.  Secondary:   Time to Treatment Failure   [ Time Frame: every 3 weeks while on treatment ]
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3.  Secondary:   Time to Progression   [ Time Frame: every 3 weeks while on treatment, then every 3 months for 3 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  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 NOT 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.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


Publications of Results:
Gold PJ, Goldman B, Iqbal S, et al.: Cetuximab as second-line therapy in patients with metastatic esophageal cancer: a phase II Southwest Oncology Group study. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-96, 2008.


Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00096031     History of Changes
Other Study ID Numbers: CDR0000391201
S0415 ( Other Identifier: SWOG )
U10CA032102 ( US NIH Grant/Contract Award Number )
Study First Received: November 9, 2004
Results First Received: April 4, 2012
Last Updated: April 4, 2012