Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase 2 Completed 92 enrolled Seoul National University Hospital Clinical Research Center for Solid Tumor, Korea · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.

Timeline

Start: 2008-04
Primary completion: 2012-11
Completion: 2013-08

Outcome

Missed primary endpoint

paper The ORRs for induction chemotherapy in the CTP and TP arms were not different (81% vs. 82%). PMID 26304911 ↗

Publications

Lee KW, Koh Y, Kim SB, Shin SW, Kang JH, Wu HG, Sung MW, Keam B, Kim DW, Kim TM, Kim KH, Kwon TK, Hah JH, Kim IA, Ahn SH, Yoon DH, Lee SW, Kim SY, Nam SY, Jung KY, Baek SK, Hong SH, Lee SH, Heo DS. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015 Oct;20(10):1119-20. doi: 10.1634/theoncologist.2015-0208. Epub 2015 Aug 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	250 mg/m2	—
Background	Cisplatin	Other / unclassified	75 mg/m2	—
Background	Docetaxel	Small molecule	75 mg/m2	—