drugset / Trial / NCT01749956

5-FU, Aflibercept, and Radiation (RT) for Preoperative and Postoperative Patients With Stage II/III Rectal Cancer

NCT01749956

Phase 2 Completed 39 enrolled SCRI Development Innovations, LLC Sanofi · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this Phase II study will be to investigate the antiangiogenic agent, aflibercept, in combination with chemoradiation as preoperative treatment for patients with stage II/III rectal cancer, followed by 4 months of FOLFOX6 plus aflibercept adjuvantly.

Timeline

Start
2013-01
Primary completion
2015-09
Completion
2015-09

Drugs

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

Indications