Results of docetaxel plus oxaliplatin (DOCOX) with or without cetuximab in patients with metastatic gastric and/or gastroesophagel junction adenocarcinoma: Results of a randomized phase II study.

4015 Background: Advanced adenocarcinoma of the gastroesophageal junction and/or stomach is standardly treated by combination chemotherapy with minimal improvements in survival. This study evaluated the value of adding cetuximab (C) to combination chemotherapy in this disease. Methods: The primary objective of this noncomparative study was progression-free survival (PFS); secondary objectives were 1-yr survival, response rate, time to response (TTR), duration of response (DOR), and safety. Treatment (Tx): Arm 1: DOCOX = docetaxel 60 mg/m2 plus oxaliplatin 130 mg/m2 on Day 1 of each 21-day cycle. Arm 2: DOCOX + C = DOCOX with C 400 mg/2 1st dose, then 250 mg/m2weekly. Key inclusion: stage IV adenocarcinoma of the GEJ/stomach; measurable disease; ECOG 0-2; and normal renal, hepatic, and marrow function; exclusion: any prior Tx other than adjuvant radiation with 5-FU/leucovorin. Results: 150 pts enrolled; 75/arm. Demographics Arm 1/2: male 79%/80%, median age 61/64 yrs; disease site: gastric 44%/41%, GEJ 51%...