Induction Chemo Then Concurrent Chemoradiotherapy With Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer
Status:
Terminated
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
This is an open label, single arm Phase II study of induction chemotherapy followed by
concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell
cancer (HNSCC) using monoclonal antibody cetuximab. Those patients with locally advanced
HNSCC deemed to be candidates for definitive concurrent chemo-radiotherapy will be treated
initially with 6 weeks of PCC (Paclitaxel, cetuximab and Carboplatin). This will be followed
by a week of no treatment for interim evaluation, followed by definitive concurrent
chemo-radiotherapy using 70Gy radiation with weekly cetuximab and cisplatin for 7 weeks. The
hypothesis of the study is that the use of cetuximab during induction chemotherapy followed
by cetuximab concurrent with chemoradiotherapy using low dose weekly cisplatin will improve
local control as well as distant spread.
Phase:
Phase 2
Details
Lead Sponsor:
Louisiana State University Health Sciences Center Shreveport