A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed primary squamous cell or adenocarcinoma* of the esophagus or
gastroesophageal junction

- Patients with involvement of the gastroesophageal junction with Siewert type I
or II tumors (tumors arising from the distal esophagus and involving the
esophagogastric junction or tumors starting at the esophagogastric junction and
involving the cardia) are eligible

- Patients with cervical esophageal carcinoma are eligible

- Patients with celiac, perigastric, mediastinal, or supraclavicular adenopathy
are eligible NOTE: * The adenocarcinoma stratum is closed as of 5/3/2012.

- Stage T1, N1, M0; T2-4, Any N, M0; or Any T, Any N, M1a disease based on
history/physical examination, endoscopy with biopsy, AND PET/PET-CT scan or
chest/abdominal CT scan within 6 weeks prior to registration

- Disease must be encompassed in a radiotherapy field

- No evidence of tracheoesophageal fistulas or invasion into the trachea or major
bronchi

- Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo
bronchoscopy to exclude fistula

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- ANC ≥ 1,500/mm³

- Platelets ≥ 100,000 cells/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL
allowed)

- Creatinine ≤ 1.5 mg/dL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT ≤ 3 times ULN

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Total intake (oral/enteral) must be ≥ 1,500 kCal/day

- No prior invasive malignancy except nonmelanomatous skin cancer (e.g., carcinoma in
situ of the breast, oral cavity, or cervix) unless disease-free for ≥ 2 years

- No prior allergic reaction to the study drugs

- No prior severe infusion reaction to a monoclonal antibody

- No severe, active comorbidity, including any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 3 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- Acquired immune deficiency syndrome based upon current CDC definition

- HIV testing is not required for entry into this study

PRIOR CONCURRENT THERAPY:

- No prior systemic chemotherapy for esophageal cancer (prior chemotherapy for another
cancer allowed)

- No prior therapy that specifically and directly targets the EGFR pathway

- No prior platinum-based and/or paclitaxel-based therapy

- No prior radiotherapy that would result in overlap of planned study radiotherapy
fields

- No concurrent investigational agent

- No concurrent cytotoxic agent

- No other concurrent radiotherapy