BrUOG-EG-203 Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer

The primary objective of this phase II trial is to estimate the rate of complete pathologic
response as determined by surgical resection or post treatment endoscopy (for patients not
undergoing resection) for the treatment regimen being tested. With a total accrual of 28
evaluable patients.

Inclusion Criteria:

- Patients are required to have pathologically confirmed adenocarcinoma or squamous cell
carcinoma of the esophagus, gastroesophageal junction, or stomach.

- Patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric
lymphadenopathy.

- There must be no evidence of distant organ metastases.

- No prior radiation for gastric or esophageal cancer.

- Patients must be > 18 years of age, and nonpregnant

- Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2 x upper
limit normal (ULN) and bilirubin < 1.5 x ULN, and AST < 3 x ULN.

- ECOG performance status 0-2.

- Patients must not have significant infection or other coexistent medical condition
that would preclude protocol therapy.

- Female patients, must either be not of child bearing potential or have a negative
pregnancy test within 7 days of starting study treatment. Patients are considered not
of child bearing potential if they are surgically sterile (they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
postmenopausal. Pregnant or lactating females are not eligible.

- All patients must sign informed consent

Exclusion Criteria:

Any of the following criteria will make the patient ineligible to participate in this
study:

- Acute hepatitis or AIDS.

- Active or uncontrolled infection.

- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
congestive heart failure, and cardiomyopathy with decreased ejection fraction.

- Prior therapy which specifically and directly targets the EGFR pathway.

- Prior severe infusion reaction to a monoclonal antibody.

- Any concurrent chemotherapy not indicated in the study protocol or any other
investigational agent(s).