Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00130689
First received: August 15, 2005
Last updated: May 12, 2015
Last verified: May 2015
Results First Received: May 28, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Esophageal Cancer
Gastric Cancer
Neoplasm Metastasis
Intervention: Drug: 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
Patients enrolled from September 2005 through November 2008.

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 Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Cetuximab  
STARTED     43  
Eligible     37  
Treated     35  
COMPLETED     0 [1]
NOT COMPLETED     43  
Progressive Disease                 29  
Death                 1  
Clinical Deterioration                 4  
Withdrawal by Subject                 3  
Ineligible                 6  
[1] Since treatment duration was not fixed, patients were not considered to have completed treatment.



  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.
The analysis dataset is comprised of eligible and treated patients.

Reporting Groups
  Description
Cetuximab Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.

Baseline Measures
    Cetuximab  
Number of Participants  
[units: participants]
  35  
Age, Customized  
[units: years]
Median (Full Range)
  61  
  (42 to 81)  
Gender  
[units: participants]
 
Female     4  
Male     31  
Region of Enrollment  
[units: participants]
 
United States     35  
Primary Tumor  
[units: participants]
 
Esophagael     12  
GE Junction     8  
Gastric     15  



  Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 weeks (range 1-23 weeks). ]


  Serious Adverse Events


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


Results Point of Contact:  
Name/Title: Jennifer Ang Chan, MD, MPH
Organization: Dana-Farber Cancer Institute
phone: 617-632-6315
e-mail: jennifer_chan@dfci.harvard.edu


Publications of Results:

Responsible Party: Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00130689     History of Changes
Other Study ID Numbers: 05-113
Study First Received: August 15, 2005
Results First Received: May 28, 2014
Last Updated: May 12, 2015
Health Authority: United States: Food and Drug Administration