Randomized Phase II Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esophageal and GE Junction Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically, cytologically, or radiologically confirmed esophageal cancer,
including any of the following types:

- Squamous cell carcinoma

- Adenocarcinoma* of the esophagus

- Adenocarcinoma* of the gastroesophageal (GE) junction according to Siewert
classification

- Type I or II disease

- No type III disease NOTE: Undifferentiated adenocarcinoma and
adenosquamous tumor will be considered as adenocarcinoma

- Metastatic disease or locally recurrent or residual (post-resection) disease

- Resected esophageal or GE junction disease that develops radiological or
clinical evidence of metastatic disease does not require histological or
cytological confirmation of metastatic disease unless 1 of the following is
true:

- More than 5 years since primary surgery and development of metastatic
disease

- Primary cancer was stage I

- Measurable disease, defined as at least 1 unidimensionally measurable lesion (longest
diameter) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

- Must have ≥ 1 paraffin block (or ≥ 15 unstained slides) available for analysis of
tumor epidermal growth factor receptor (EGFR) status

- No known CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Platelet count ≥ 100,000/mm^3

- Granulocyte count ≥ 1,500/mm^3

- Creatinine ≤ 1.5 mg/dL

- AST ≤ 5.0 times upper limit of normal

- Bilirubin ≤ 1.5 mg/dL

- Albumin ≥ 2.5 g/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must have a stable weight loss of (i.e., < 1 pound weight loss during the past week)

- No diarrhea ≥ grade 2 within the past 7 days

- No myocardial infarction within the past 6 months

- No New York Heart Association class III or IV congestive heart failure

- No interstitial pneumonia or symptomatic interstitial fibrosis of the lung

- No seizure disorder or active neurological disease requiring anti-epileptic
medication

- No peripheral neuropathy ≥ grade 2

- No evidence of Gilbert's syndrome

- No prior allergic reaction to chimerized or murine monoclonal antibody therapy or
documented presence of human anti-mouse antibodies (HAMA)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy or radiotherapy

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

- At least 4 weeks since prior major surgery* and recovered

- At least 2 weeks since prior minor surgery* and recovered

- No concurrent palliative radiotherapy

- No other concurrent investigational agent

- No other concurrent chemotherapy

- No concurrent hormonal therapy except for the following:

- Steroids given temporarily for adrenal failure

- Hormones for nondisease-related conditions (e.g., insulin for diabetes)

- Intermittent steroids (e.g., dexamethasone) as an antiemetic NOTE: *Insertion of
a vascular device is not considered major or minor surgery