BrUOG-EG-203 Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT00439608
First received: February 22, 2007
Last updated: July 1, 2013
Last verified: July 2013
Results First Received: May 9, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Esophageal Cancer
Gastric Cancer
Intervention: Drug: Cetuximab,Paclitaxel, Carboplatin

  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
60 patients were enrolled at multiple hospitals and medical clinics

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
Treatment

Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer

Patients received cetuximab, 400 mg/mg2 over 2 h on Day 1 then 250 mg/m2/week over 1 h, for 5 additional weeks. Patients also received paclitaxel, 50 mg/m2/week, over 1 h and carboplatin AUC (area under the curve) = 2/week, over 30 min, for 6 weeks. Cetuximab was administered first. Patients were then monitored for 1 h. Paclitaxel was then administered followed by carboplatin. Radiation was generally administered after chemotherapy. Dexamethasone 20 mg intravenously (IV), diphenhydramine 50 mg IV, and ranitidine 50 mg IV were given 30 min before treatment. Dosages of dexamethasone and diphenhydramine could be reduced in subsequent weeks if no hypersensitivity reactions were observed.


Participant Flow:   Overall Study
    Treatment  
STARTED     60  
COMPLETED     60  
NOT COMPLETED     0  



  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.
Patients received cetuximab, 400 mg/mg2 over 2 h on Day 1 then 250 mg/m2/week over 1 h, for 5 additional weeks. Patients also received paclitaxel, 50 mg/m2/week, over 1 h and carboplatin AUC (area under the curve) = 2/week, over 30 min, for 6 weeks. Cetuximab was administered first.

Reporting Groups
  Description
Treatment No text entered.

Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  60  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     40  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 5  
Gender  
[units: participants]
 
Female     10  
Male     50  
Region of Enrollment  
[units: participants]
 
United States     60  



  Outcome Measures

1.  Primary:   Reponse Rate at Time of Surgery by Tissue   [ Time Frame: within 30 days of last treatment ]

2.  Secondary:   Measure of Safety and Tolerability According to CTC Version 3.0   [ Time Frame: 30 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Howard Safran, MD
Organization: BrUOG
phone: 401-863-3000
e-mail: Hsafran@lifespan.org


No publications provided


Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT00439608     History of Changes
Other Study ID Numbers: BrUOG-EG-203, BMS#CA225091
Study First Received: February 22, 2007
Results First Received: May 9, 2013
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board