Phase II Study Of OSI-774 In Advanced Esophageal Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell
carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal
junction

- Metastatic or surgically unresectable disease

- Measurable disease outside of primary tumor

- At least 20 mm by conventional techniques OR at least 10 mm by spiral computed
tomography (CT) scan

- No bone metastases, abnormal radionuclide bone scans, or pleural effusions as only
site of measurable disease

- No known brain metastases or carcinomatous meningitis

- Must consent to having tumor tissue tested for epidermal growth factor receptor
status

- Performance status-Karnofsky 70-100%

- Life expectancy of greater than 3 months

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- Aspartate aminotransferase (AST) no greater than 2 times ULN

- Creatinine no greater than 1.5 mg/dL

- Calcium no greater than 12 mg/dL

- No symptomatic hypercalcemia

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No ventricular arrhythmia

- No other malignancy within the past 3 years except adequately treated carcinoma in
situ of the cervix, superficial transitional cell carcinoma of the bladder, or basal
cell or squamous cell skin cancer

- No other uncontrolled concurrent illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study participation

- No other concurrent disease that would preclude study participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior cetuximab

- No more than 1 prior chemotherapy regimen for advanced or metastatic disease

- One prior chemotherapy in the adjuvant setting (in combination with prior surgery or
radiotherapy) allowed provided it was administered prior to treatment for advanced or
metastatic disease

- At least 3 weeks since prior chemotherapy

- No concurrent investigational or commercial chemotherapy

- At least 3 weeks since prior radiotherapy

- No prior erlotinib-related compounds or compounds of similar biologic or chemical
components

- No prior EGFR-targeting compounds (e.g., gefitinib)

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for human immunodeficiency virus
(HIV)-positive patients