drugset / Trial / NCT01747551

FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer

NCT01747551

Phase 2 Completed 64 enrolled Dana-Farber Cancer Institute
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2013-01
Primary completion
2016-11-29
Completion
2017-07-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aflibercept Protein / enzyme biologic 4 mg/kg Intravenous
Comparator Leucovorin Small molecule 400 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 85 mg/m2 Intravenous
Comparator fluorouracil Small molecule 400 mg/m2 Intravenous
Comparator fluorouracil Small molecule 2400 mg/m2 Intravenous