A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC

Summary

The primary objective is to investigate the objective response rate in patients receiving GEMOX (gemcitabine plus oxaliplatin) plus cetuximab as first line treatment in advanced or metastatic unresectable BTC biliary tract cancer compared to patients receiving the same chemotherapy without cetuximab. The secondary objectives include the exploration of the effect of the multimodality strategy on progression-free and overall survival, biomarker prediction, and toxicity.

Timeline

Start

2010-12

Primary completion

2013-12

Completion

2015-05

Outcome

Missed primary endpoint

paper Compared with GEMOX alone, C-GEMOX was associated with trend to better ORR (27% versus 15%; P = 0.12) PMID 25632066 ↗

paper Addition of cetuximab did not significantly improve the ORR of GEMOX chemotherapy in ABTC PMID 25632066 ↗

Publications

• Chen JS, Hsu C, Chiang NJ, Tsai CS, Tsou HH, Huang SF, Bai LY, Chang IC, Shiah HS, Ho CL, Yen CJ, Lee KD, Chiu CF, Rau KM, Yu MS, Yang Y, Hsieh RK, Chang JY, Shan YS, Chao Y, Chen LT; Taiwan Cooperative Oncology Group. A KRAS mutation status-stratified randomized phase II trial of gemcitabine and oxaliplatin alone or in combination with cetuximab in advanced biliary tract cancer. Ann Oncol. 2015 May;26(5):943-949. doi: 10.1093/annonc/mdv035. Epub 2015 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	500 mg/m2	Intravenous
Comparator	Gemcitabine	Small molecule	800 mg/m2	Intravenous
Comparator	Oxaliplatin	Small molecule	85 mg/m2	Intravenous

Indications