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

Inclusion Criteria:

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
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.
Previously untreated with chemotherapeutic agents for unresectable or metastatic disease.
Adjuvant chemotherapy and/or radiotherapy are allowed as long as no oxaliplatin was used in the past 12 months.
ECOG performance status 0 or 1
Age > 18 years old.
Life expectancy greater than 6 months.
Peripheral neuropathy: must be < grade 1
Absolute neutrophil count > 1,500/mm3
Hemoglobin > 9.0 g/dl
Platelet count > 100,000/mm3

Hepatic Function:

Total Bilirubin < or = to 1.5 x ULN
AST and ALT must be < or = to 3.0 x ULN (< or = to 5.0 x ULN if there is liver metastasis).

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)

Women of childbearing potential must have a negative pregnancy test by urine or serum testing.
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.
Patients must have signed IRB approved informed consent
Patients must have the ability to comply with study and follow-up procedures.

Exclusion Criteria:

Patients with known hypersensitivity to any components of oxaliplatin, leucovorin, 5-fluorouracil (or other fluoropyrimidines) or erlotinib.
Women who are breast-feeding or pregnant.
Presence of > Grade 2 neuropathy
Patients with prior malignancy other than non-melanoma skin cancer or cervical carcinoma in situ within the past five years
Current or prior history of central nervous system or brain metastases
Any other medical conditions, which, in the opinion of the investigator, would preclude subjects to participate in the study.
Patients who have received chemotherapy, surgery or radiation therapy within 30 days prior to the first dose.
INR greater than 3.5 for patients on warfarin
Known HIV infection