Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed adenocarcinoma of the stomach\* or gastroesophageal (GE) junction
• •* GE junction tumors include esophageal tumors arising 5 cm from the anatomic GE junction or in the gastric cardia
• •* Locally advanced (i.e., unresectable) or metastatic disease NOTE: \*Gastric stratum temporarily closed to accrual as of 03/01/2003
• •Unidimensionally measurable disease
• •* Target lesion must not be in previously irradiated field unless there is documentation of clear progression
• •No known brain metastases
• •PATIENT CHARACTERISTICS:
• •Age:
• •Not specified
• •Performance status:
• •Zubrod 0-1
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic:
• •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• •SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver metastases present)
• •Renal:
• •Creatinine no greater than 2 times ULN
• •Cardiovascular:
• •No recent myocardial infarction
• •No unstable angina
• •No life-threatening arrhythmia
• •Gastrointestinal:
• •No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
• •No active peptic ulcer disease
• •Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube
• •No intractable nausea or vomiting
• •Ophthalmic:
• •No history of corneal disease, including:
• •* Dry eye syndrome or Sjögren's syndrome
• •* Keratoconjunctivitis sicca
• •* Exposure keratopathy
• •* Fuch's dystrophy
• •* Other active disorders of the cornea
• •Other:
• •HIV negative
• •No active or uncontrolled infection
• •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• •No severe psychiatric disorders
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No prior biologic therapy
• •No concurrent anticancer immunotherapy
• •Chemotherapy:
• •No prior chemotherapy for advanced or metastatic gastric cancer
• •At least 8 weeks since prior adjuvant chemotherapy or chemotherapy given as a radiosensitizer and recovered
• •No concurrent anticancer chemotherapy
• •Endocrine therapy:
• •No concurrent anticancer hormonal therapy
• •Radiotherapy:
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy and recovered
• •No concurrent anticancer radiotherapy
• •Surgery:
• •At least 4 weeks since prior surgical procedure for stomach\* or GE cancer and recovered
• •No prior surgical procedures that would affect absorption NOTE: \*Gastric stratum temporarily closed to accrual as of 03/01/2003
• •Other:
• •No prior investigational drugs
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No other concurrent anticancer therapy