Trial of Preoperative Capecitabine Oxaliplatin Cetuximab & Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

This study is currently recruiting participants.

Verified by University of Colorado at Denver and Health Sciences Center, February 2007

First Received: January 30, 2007 Last Updated: February 27, 2007 History of Changes

Sponsors and Collaborators:	University of Colorado at Denver and Health Sciences Center Bristol-Myers Squibb Sanofi-Aventis
Information provided by:	University of Colorado at Denver and Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00430027

Purpose

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	Intervention
Esophageal Adenocarcinoma	Drug: Capecitabine Drug: Oxaliplatin Drug: Cetuximab

MedlinePlus related topics: Esophagus Disorders Radiation Therapy

Drug Information available for: Oxaliplatin Capecitabine Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Feasibility Trial of Preoperative Capecitabine, Oxaliplatin, Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

Primary Outcome Measures:

Overall toxicity
Pathological complete response
Down-staging
Local control at 2 years
Survival at 2 years
PET response
Skin rash severity
Correlated outcomes and measures
Feasibility and compliance

Estimated Enrollment:	15
Study Start Date:	November 2006

Detailed Description:

It is clear that new approaches are needed to improve the therapeutic ratio in esophageal cancer. This study proposes to evaluate the noval 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 thoraco-abdominal radiation therapy will be feasible and result in acceptable toxicity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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 GE junction must be limited to no greater than 2 cm into the gastric cardia
clinical stage T3, NO-1 or T1-2, N1 and MO or M1a (celiac axis lymph nodes are allowed)
Karnosfsky Performance Status of >60%
FeV1 must be >1.0 L
adequate bone marrow reserve equal to or ANC > 1500/mcl, total 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, ALT, 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 attemped resection of an esophageal cancer
women who are pregnant or lactating
life expectancy < 3 months
serious, uncontrolled concurrent infection(s)
prior fluorophrimidine therapy
prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known 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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430027

Contacts

Contact: Tracey Schefter, MD

720-848-0737

Tracey.Schefter@uchsc.edu

Locations

United States, Colorado
University of Colorado at Denver and Health Science Center	Recruiting
Aurora, Colorado, United States, 80045
Contact: Tracey Schefter, MD 720-848-0737 Tracey.Schefter@uchsc.edu
Principal Investigator: Tracey Schefter, MD

Sponsors and Collaborators

University of Colorado at Denver and Health Sciences Center

Bristol-Myers Squibb

Sanofi-Aventis

Investigators

Principal Investigator:

Tracey Schefter, MD

University of Colorado at Denver and Health Science Center

More Information

No publications provided

Study ID Numbers:	NCT00060011
Study First Received:	January 30, 2007
Last Updated:	February 27, 2007
ClinicalTrials.gov Identifier:	NCT00430027 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Colorado at Denver and Health Sciences Center:

Esophageal
Esophagus

Study placed in the following topic categories:

Antimetabolites
Oxaliplatin
Capecitabine
Digestive System Diseases
Esophageal Disorder
Gastrointestinal Diseases

Cetuximab
Esophageal Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Cetuximab
Pharmacologic Actions

Carcinoma
Neoplasms
Oxaliplatin
Digestive System Diseases
Therapeutic Uses
Esophageal Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009