drugset / Trial / NCT01285778

Vectibix for the Treatment of Anal Cancer

NCT01285778

NaSingle-groupOpen-labelTreatment

Summary

Chemoradiation with 5-FU and Mitomycin C is the standard treatment in anal canal SCC. Panitumumab has shown efficacy in other tumors and anti-EGFR treatment has shown clinical activity in a single report of a refractory anal canal SCC patient. Based on this background, we propose to conduct a phase II study to investigate the efficacy and toxicity of radiotherapy with the association: * 5-FU 1000mg/m2 on days 1-4 and 29-32 * Mitomycin C 10mg/m2 on days 1 and 29 * Panitumumab 6 mg/kg on day 1, then every 2 weeks for 8 weeks

Timeline

Start
2010-10
Primary completion
2017-03-24
Completion
2017-03-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitomycin C Other / unclassified 10 mg/m2
Subject Panitumumab Monoclonal antibody 6 mg/kg Intravenous
Subject fluorouracil Small molecule 1000 mg/m2