• Toxicity [ Designated as safety issue: Yes ]
• Degree of dysphagia relief [ Designated as safety issue: No ]
• Time to progression [ Designated as safety issue: No ]
• Overall survival [ Designated as safety issue: No ]

• Toxicity
• Degree of dysphagia relief
• Time to progression
• Overall survival

RATIONALE: Erlotinib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying erlotinib to see how well it works in treating patients with advanced esophageal cancer or stomach cancer.

OBJECTIVES:

• Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib.
• Determine the overall survival of patients treated with this drug.
• Determine the degree of dysphagia relief in patients treated with this drug.
• Determine the toxicity and tolerability of this drug in these patients.
• Correlate epidermal growth factor receptor (EGFR) expression with response to treatment in these patients.

OUTLINE: This is a non-randomized study. Patients are stratified according to epidermal growth factor receptor status (positive vs negative).

Patients receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 18-48 patients (9-24 per stratum) will be accrued for this study within 2 years.

DISEASE CHARACTERISTICS:

• 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 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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

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

Renal

• Creatinine no greater than 1.5 mg/dL
• Calcium no greater than 12 mg/dL
• No symptomatic hypercalcemia

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No ventricular arrhythmia

Other

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior cetuximab

Chemotherapy

• 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

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy
• At least 3 weeks since prior radiotherapy

Surgery

• See Chemotherapy

Other

• 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 HIV-positive patients