Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Esophageal Cancer
Intervention: Biological: cetuximab

  Participant Flow
  Hide Participant Flow

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

Baseline Measures
    Cetuximab  
Number of Participants  
[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
  Show All Outcome Measures

1.  Primary:   Overall Survival at 6 Months   [ Time Frame: every 3 weeks while on treatment, then every 3 months ]
  Show Outcome Measure 1

2.  Secondary:   Time to Treatment Failure   [ Time Frame: every 3 weeks while on treatment ]
  Show Outcome Measure 2

3.  Secondary:   Time to Progression   [ Time Frame: every 3 weeks while on treatment, then every 3 months for 3 years ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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, U10CA032102
Study First Received: November 9, 2004
Results First Received: April 4, 2012
Last Updated: April 4, 2012
Health Authority: United States: Federal Government