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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Description
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Brief Summary:
The primary objective of this pilot study is 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 and tolerable.

Condition or disease Intervention/treatment Phase
Esophageal Adenocarcinoma Drug: Capecitabine Drug: Oxaliplatin Drug: Cetuximab Not Applicable

Detailed Description:
It is clear that new approaches are needed to improve the therapeutic ratio in esophageal cancer. This study proposes to evaluate the novel combination of preoperative capecitabine, oxaliplatin, and cetuximab concurrently with radiation therapy. This will be followed by esophagectomy 6-9 weeks after the completion of chemoradiation. Followed by further adjuvant chemotherapy. It is hypothesized that our novel combination of neoadjuvant capecitabine, oxaliplatin, and cetuximab combined with thoracoabdominal radiation therapy will be feasible and result in acceptable toxicity.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Feasibility Trial of Preoperative Capecitabine, Oxaliplatin, Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma
Study Start Date : November 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Capecitabine, oxaliplatin, cetuximab, and radiation therapy
Patients enrolled on the trial will receive neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This will be followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
 Drug: Capecitabine
Given 650 mg/m^2 BID on days of ration therapy, 825 mg/m^2 day 1-14, day 15-20 off x 4
Other Name: Xeloda

Drug: Oxaliplatin
Oxaliplatin 30 mg/m^2, 130mg/m2 IV Q 21 days x 4
Other Name: Eloxatin

Drug: Cetuximab
Initial Cetuximab 400 mg/m^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection
Other Name: Erbitux


Outcome Measures
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Primary Outcome Measures :
  1. Overall Toxicity [ Time Frame: Up to 4 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed informed consent
  • patients 18 years of age or older
  • biopsy proven, non-recurrent primary adenocarcinoma of the thoracic esophagus or gastro-esophageal junction, disease confined to esophagus and peri-esophageal soft tissue, tumors at the gastroesophageal junction must be limited to no greater than 2 cm into the gastric cardia
  • clinical stage T3, N0-1 or T1-2, N1 and M0 or M1a (celiac axis lymph nodes are allowed)
  • Karnofsky Performance Status of >60%
  • forced expiratory volume at one second (FeV1) must be >1.0 L
  • adequate bone marrow reserve equal to or absolute neutrophil count (ANC) > 1500/mcl, total white blood cell count (WBC) > 3000/mcl, platelets >100,000/mcl and hemoglobin > 10.0 g/dl (transfusion permitted)
  • adequate hepatic function of direct serum bilirubin < 2 times the upper limit of normal, total bilirubin < 1.5 times the upper limit normal, alanine transaminase (ALT), aspartate transaminase (AST) < 2.5 times the upper limit normal, Alkaline phosphatase < 2.5 times the upper limit normal
  • creatinine clearance > 50 ml/min
  • female patients of childbearing potential must have a negative serum or urin pregnancy test within 7 days prior to starting therapy

Exclusion Criteria:

  • no previous resection or attempted resection of an esophageal cancer
  • women who are pregnant or lactating
  • life expectancy < 3 months
  • serious, uncontrolled concurrent infection(s)
  • prior fluoropyrimidine therapy
  • prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known Dihydro Pyrimidine Dehydrogenase Deficiency (DPD) deficiency
  • treatment for other carcinomas within 5 years, except cured non-melanoma skin and treated in-situ cervical cancer
  • history of or evidence of uncontrolled diabetes
  • surgical procedure within 6 months of study entry
  • participation in any investigational drug study within 4 weeks preceding the start of study treatment
  • prior therapy with andy agent that specifically targets the Epidermal Growth Factor Receptor (EGFR) pathway
  • prior severe infusion reaction to a monoclonal antibody
  • acute hepatitis or known HIV
  • clinically significant cardia disease
  • evidence of metastases
  • other serious uncontrolled medical conditions that the investigator feels might compromise study participation
  • major surgery within 4 weeks of the start of treatment without complete recovery
  • lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  • known, existing uncontrolled coagulopathy
  • unwillingness to give written informed consent
  • unwillingness to participate or inability to comply with the protocol for the duration of the study
  • neuropathy of grade 2 or greater
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430027


Locations
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United States, Colorado
University of Colorado at Denver and Health Science Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Bristol-Myers Squibb
Sanofi
Investigators
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Principal Investigator: Tracey Schefter, MD University of Colorado at Denver and Health Science Center
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00430027    
Other Study ID Numbers: 06-0011.cc
First Posted: February 1, 2007    Key Record Dates
Results First Posted: December 12, 2013
Last Update Posted: December 12, 2013
Last Verified: October 2013
Keywords provided by University of Colorado, Denver:
Esophageal
Esophagus
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
 Esophageal Diseases
Gastrointestinal Diseases
Capecitabine
Oxaliplatin
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological