sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

The primary objective is to determine the clinical efficacy of treatment regimen in terms of objective response rate (ORR). The secondary objectives is to determine the clinical efficacy of the study treatment in terms of progression free survival (PFS) and overall survival (OS). Additionally, to characterize the safety and toxicity profile of the study treatment as measured by the adverse event rates.

Inclusion Criteria: * Histologically and/or cytologically confirmed metastatic or unresectable adenocarcinoma of esophageal, gastroesophageal junction or gastric origin * Tumor is HER2 negative by standard local testing methodology * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 - 2 * Measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1 * No prior systemic therapy for the present cancer given in the metastatic setting and \> 6 months from administration of peri-operative chemotherapy, if applicable o Note: up to two prior cycles of mFOLFOX6 for the present illness is permitted if patients otherwise qualify for the study with adequate baseline imaging * At least 18 years of age * Adequate bone marrow and organ functions as defined by: * Absolute neutrophil count ≥ 1500 cells/ μL * Hemoglobin ≥ 8 g/ dL * Platelets \> 100,000 / μL * Creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault * Total bilirubin ≤ ULN * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) \< 2.5 x ULN, unless with liver metastases and then must be \