Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia

Inclusion Criteria

• •1. Metastatic or unresectable adenocarcinoma of the upper gastrointestinal tract that can be measured in at least one dimension according to RECIST criteria by CT or MRI
• •2. Gastric adenocarcinomas may be included if the primary tumor arises within 5 cm of the anatomic gastro-esophageal junction (distal esophagus) or from the gastric cardia as indicated by either endoscope or imaging.
• •3. Previously untreated with chemotherapeutic agents for unresectable or metastatic disease.
• •4. Adjuvant chemotherapy and/or radiotherapy are allowed as long as no oxaliplatin was used in the past 12 months.
• •5. ECOG performance status 0 or 1
• •6. Age \> 18 years old.
• •7. Life expectancy greater than 6 months.
• •8. Peripheral neuropathy: must be \< grade 1
• •9. Absolute neutrophil count \> 1,500/mm3
• •10. Hemoglobin \> 9.0 g/dl
• •11. Platelet count \> 100,000/mm3
• •12. Hepatic Function:
• •1. Total Bilirubin \< or = to 1.5 x ULN
• •2. AST and ALT must be \< or = to 3.0 x ULN (\< or = to 5.0 x ULN if there is liver metastasis).
• •13. Creatinine clearance of \> 60 ml/min as calculated by the Cockcroft Gault formula. (Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) for males).
• •(Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) x 0.85 for females)
• •14. Women of childbearing potential must have a negative pregnancy test by urine or serum testing.
• •15. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 4 months after the last treatment.
• •16. Patients must have signed IRB approved informed consent
• •17. Patients must have the ability to comply with study and follow-up procedures.