Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas

Phase 2 Terminated 25 enrolled Gabi Chiorean, MD OSI Pharmaceuticals · collab Sanofi · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

An unmet medical need exists for the successful therapy of patients with advanced hepatocellular and biliary tract malignances, with few and short lived disease responses to chemotherapy for both advanced stage hepatic and biliary carcinomas. Pre-clinical data shows cooperative antitumor activity between an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor and taxanes. The efficacy of erlotinib in combination with docetaxel will be assessed in this trial.

Timeline

Start: 2007-09
Primary completion: 2010-08
Completion: 2010-08

Outcome

Met primary endpoint

Stopped (Business): “Terminated due to funding issues.”

paper Conclusion: Erlotinib with docetaxel met the 16-week PFS ≥ 30% endpoint PMID 22210086 ↗

Publications

Results Chiorean EG, Ramasubbaiah R, Yu M, Picus J, Bufill JA, Tong Y, Coleman N, Johnston EL, Currie C, Loehrer PJ. Phase II trial of erlotinib and docetaxel in advanced and refractory hepatocellular and biliary cancers: Hoosier Oncology Group GI06-101. Oncologist. 2012;17(1):13. doi: 10.1634/theoncologist.2011-0253. Epub 2011 Dec 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	30 mg/m2	Intravenous
Subject	Erlotinib	Small molecule	150 mg	Oral