FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer
Status:
Completed
Trial end date:
2017-07-26
Target enrollment:
Participant gender:
Summary
Anti-angiogenic therapy is a proven therapeutic target in refractory gastric and
gastroesophageal junction adenocarcinoma. This trial assessed whether the addition of a high
affinity angiogenesis inhibitor, ziv-aflibercept, could improve the efficacy of first-line
mFOLFOX6 (oxaliplatin, leucovorin, and bolus plus infusional 5- fluorouracil) chemotherapy in
metastatic esophagogastric adenocarcinoma.
In this study (ZAMEGA), patients with treatment-naïve esophagogastric adenocarcinoma were
randomly assigned 2:1 in a multicenter, placebo-controlled double-blind trial to receive
first-line mFOLFOX6 with or without ziv-aflibercept 4mg/kg every 2 weeks. Randomization was
stratified by ECOG performance status (0-1 vs. 2) and primary site of disease (esophagus or
GE junction vs stomach).