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Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT00430027
Recruitment Status : Terminated (This study was terminated due slow accrual.)
First Posted : February 1, 2007
Results First Posted : December 12, 2013
Last Update Posted : December 12, 2013
Sponsor:
Collaborators:
Bristol-Myers Squibb
Sanofi
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Esophageal Adenocarcinoma
Interventions Drug: Capecitabine
Drug: Oxaliplatin
Drug: Cetuximab
Enrollment 8
Recruitment Details Between November 2006 and August 2008, 8 patients were enrolled in the study from the Radiation Oncology clinic.
Pre-assignment Details This was to be a pilot/feasibility trial with a maximum of 15 patients enrolled, with the intent to propose a phase II trial. The study stopped before enrolling 15 patients, therefore the phase II trial was not pursued.
Arm/Group Title Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy
Hide Arm/Group Description Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
Period Title: Overall Study
Started 8
Completed 0
Not Completed 8
Reason Not Completed
Study terminated             8
Arm/Group Title Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy
Hide Arm/Group Description Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  50.0%
>=65 years
4
  50.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
64.0  (10.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
2
  25.0%
Male
6
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Overall Toxicity
Hide Description The primary objective of this pilot study was to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab is feasible with acceptable toxicity profile.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated, study end points were not reached.
Arm/Group Title Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy
Hide Arm/Group Description:
Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Participants were monitored for approximately 2 years.
Adverse Event Reporting Description Patients were assessed weekly at their clinic visits.
 
Arm/Group Title Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy
Hide Arm/Group Description Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
All-Cause Mortality
Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy
Affected / at Risk (%) # Events
Total   1/8 (12.50%)    
Infections and infestations   
Infection  1 [1]  1/8 (12.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Septic shock
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Blood and lymphatic system disorders   
Lymphopenia  1  6/8 (75.00%)  21
Cardiac disorders   
Pericardial effusion  1  1/8 (12.50%)  1
Atrial fibrillation  1  1/8 (12.50%)  1
Gastrointestinal disorders   
Nausea  1  1/8 (12.50%)  2
Vomiting  1  1/8 (12.50%)  2
Dysphagia  1  1/8 (12.50%)  2
Distension  1  1/8 (12.50%)  1
General disorders   
Fatigue  1  1/8 (12.50%)  1
Pain  1 [1]  1/8 (12.50%)  1
Immune system disorders   
Hypersensitivity  1  2/8 (25.00%)  2
Investigations   
INR  1  3/8 (37.50%)  11
Metabolism and nutrition disorders   
Anorexia  1  2/8 (25.00%)  2
Dehydration  1  2/8 (25.00%)  3
Hyperglycemia  1  2/8 (25.00%)  2
Hyponatremia  1  1/8 (12.50%)  1
Hypophosphatemia  1  2/8 (25.00%)  4
Renal and urinary disorders   
Renal failure  1  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/8 (12.50%)  1
Pleural effusion  1  1/8 (12.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Abdominal cramping
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tracey Schefter
Organization: University of Colorado, Denver
Phone: 720-848-0100
EMail: Tracey.Schefter@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00430027     History of Changes
Other Study ID Numbers: 06-0011.cc
First Submitted: January 30, 2007
First Posted: February 1, 2007
Results First Submitted: October 22, 2013
Results First Posted: December 12, 2013
Last Update Posted: December 12, 2013