A Phase II Study of Neoadjuvant Therapy With Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of the Distal Esophagus

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Biopsy-proven adenocarcinoma of the distal esophagus or gastroesophageal junction,
meeting all of the following criteria:

- Siewert type I or II disease

- Newly diagnosed disease (nonrecurrent)

- Resectable disease

- Clinical stage T1-3,N1,M0; T3,N0,M0; or T1-3,N0-1,M1a (celiac adenopathy must be ≤ 2
cm by esophageal ultrasound) disease

- No T1 tumors or T2,N0,M0 tumors allowed

- Locally advanced disease

- No definitive radiological evidence of distant metastases

PATIENT CHARACTERISTICS:

- ECOG/Zubrod performance status 0-1

- WBC ≥ 3,000/mm³

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.5 g/dL

- Creatinine ≤ 1.5 mg/dL

- Total bilirubin ≤ 3 mg/dL

- AST and ALT ≤ 2.0 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.0 times ULN

- Albumin ≥ 2.0 g/dL OR prealbumin ≥ 15 mg/dL

- Magnesium ≥ lower limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- No pre-existing peripheral neuropathy of any etiology ≥ grade 2 (CTCAE V3)

- No prior invasive malignancy, unless disease-free for ≥ 5 years before registration,
except for nonmelanoma skin cancer or in situ cancers

- No uncontrolled intercurrent illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study
requirements

- No history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or
any evidence of interstitial lung disease on baseline chest CT scan

- No history of any medical or psychiatric condition or laboratory abnormality that, in
the opinion of the investigator, may increase the risks associated with the study
participation or investigational product(s) administration or may interfere with the
interpretation of the results

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy to chest or upper abdomen

- No prior cisplatin, docetaxel, panitumumab, or other anti-EGFR therapy

- No prior esophageal or gastric surgery

- Prior surgery to treat reflux disease allowed

- No other concurrent antineoplastic or antitumor agents, including chemotherapy,
radiotherapy, immunotherapy, or hormonal anticancer therapy

- No concurrent investigational agents