Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach 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