Cetuximab + Gemox in Biliary Tract Cancer

Summary

The aim of this prospective single-centre phase II study is to investigate the therapeutic efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in the palliative first line treatment of biliary tract cancer (BTC) patients.

Timeline

Start

2006-10

Primary completion

2008-10

Completion

2009-10

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The primary outcome was overall response rate. PMID 21071270 ↗

paper Objective response occurred in 19 patients (63%; 95% CI 56·2-69·8) PMID 21071270 ↗

Publications

• Results Gruenberger B, Schueller J, et al: K-ras status and response in patients with advanced or metastatic cholangiocarcinoma treated with cetuximab plus gemcitabine-oxaliplatin (GEMOX): a single center phase II study J Clin Oncol 27:15s, 2009 (suppl; abstr 4586)
• Gruenberger B, Schueller J, Heubrandtner U, Wrba F, Tamandl D, Kaczirek K, Roka R, Freimann-Pircher S, Gruenberger T. Cetuximab, gemcitabine, and oxaliplatin in patients with unresectable advanced or metastatic biliary tract cancer: a phase 2 study. Lancet Oncol. 2010 Dec;11(12):1142-8. doi: 10.1016/S1470-2045(10)70247-3. Epub 2010 Nov 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	500 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	100 mg/m2	Intravenous

Indications