A Phase 2 Randomized Study to Measure Response Rate and Toxicity of Oxaliplatin/5-FU Plus Cetuximab Followed by Post-Operative Docetaxel and Cetuximab in Patients With Operable Adenocarcinoma of the Esophagus

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
meeting the following criteria:

- Newly diagnosed disease

- Tumor is ≥ 20 cm below the incisors

- Tumor extending ≤ 2 cm into cardia

- Tumors must be considered surgically resectable (T1-3)

- No T4 tumors

- Stage T2 N0 M0, T3 N0 M0, T1-3 N+ M0, or T1-3 N0-1 M1a by imaging studies (and biopsy
when appropriate) performed within the past 4 weeks

- M1a disease (i.e., celiac nodal metastasis) is allowed provided other
eligibility criteria are met

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Granulocytes > 1,000/ mm³

- Platelets > 100,000/mm³

- Creatinine normal or creatinine clearance > 60 mL/min

- Total serum bilirubin < 1.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- History of a curatively treated malignancy from which the patient has been
disease-free for ≥ 2 years and has a survival prognosis of > 5 years

- Patients with a history of breast cancer remaining on hormonal treatment > 5 years
are eligible

- No prior severe infusion reaction to a monoclonal antibody

- No infection

- No hypertension

- No uncontrolled diabetes

- No intercurrent illness that would likely interfere with protocol therapy or prevent
surgical resection

- None of the following within the past 6 months:

- New York Heart Association class III-IV congestive heart failure

- Cerebrovascular accident or transient ischemic attack

- Unstable angina or myocardial infarction

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy, radiotherapy, or surgery

- Endoscopy with biopsy and dilation is allowed

- No prior therapy specifically and directly targeting the EGFR pathway