drugset / Trial / NCT01843452

Phase II Study of Concomitant Intensity-modulated Radiotherapy Combined to Capecitabine, Mitomycin and Panitumumab in Patients With Stage II-IIIB Squamous-cell Carcinoma of the Anal Canal

NCT01843452

Phase 2 Terminated 8 enrolled Centre Hospitalier Universitaire Vaudois
NaSingle-groupOpen-labelTreatment

Summary

There is increasing evidence of a role of EGFR, treatment with EGFR-inhibitors in anal cancer and synergies of EGFR-inhibitors with radiotherapy. Addition of the human anti-EGFR antibody Panitumumab to chemoradiotherapy seems therefore solidly justified. This trial investigates concurrent panitumumab/capecitabine/mitomycin concurrent to IMRT-radiotherapy. Treatment components used in this study have been selected on scientific rationale. The trial regimen should be feasible with acceptable toxicity and outcome similar to historic series.

Timeline

Start
2012-12
Primary completion
2016-05
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 825 mg/m2 Oral
Subject Mitomycin C Other / unclassified 10 mg/m2 Intravenous
Subject Panitumumab Monoclonal antibody 6 mg/kg Intravenous