Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study

Phase 2 Completed 43 enrolled Cliniques universitaires Saint-Luc- Université Catholique de Louvain Merck Sharp & Dohme LLC · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this phase II study is to assess the efficacy of combined chemotherapy using gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.

Timeline

Start: 2008-09
Primary completion: 2010-09
Completion: 2010-09

Outcome

Met primary endpoint

paper Our study met its primary end point, suggesting that Gemcitabine-Cetuximab has activity in cholangiocarcinoma. PMID 23975665 ↗

Publications

Borbath I, Ceratti A, Verslype C, Demols A, Delaunoit T, Laurent S, Deleporte A, Vergauwe P, Van Maanen A, Sempoux C, Van Cutsem E, Van Laethem JL; Belgian Group of Digestive Oncology. Combination of gemcitabine and cetuximab in patients with advanced cholangiocarcinoma: a phase II study of the Belgian Group of Digestive Oncology. Ann Oncol. 2013 Nov;24(11):2824-9. doi: 10.1093/annonc/mdt337. Epub 2013 Aug 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	250 mg/m2	—
Subject	Gemcitabine	Small molecule	1000 mg/m2	—

Indications

No indication recorded.