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Pilot Feasibility Trial of Preoperative Capecitabine, Oxaliplatin, Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

18 Years
Not Enrolling
Esophageal Adenocarcinoma

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Trial Information

Pilot Feasibility Trial of Preoperative Capecitabine, Oxaliplatin, Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma

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.

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, NO-1 or T1-2, N1 and MO or M1a (celiac axis lymph nodes are

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall toxicity

Outcome Description:

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 with acceptable toxicity profile.

Outcome Time Frame:

Up to 4 weeks

Safety Issue:


Principal Investigator

Tracey Schefter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado at Denver and Health Science Center


United States: Food and Drug Administration

Study ID:



Start Date:

November 2006

Completion Date:

August 2008

Related Keywords:

  • Esophageal Adenocarcinoma
  • Esophageal
  • Esophagus
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases



University of Colorado at Denver and Health Science Center Aurora, Colorado  80045