drugset / Trial / NCT01505413

Phase 2 Study of Erlotinib, Gemcitabine and Oxaliplatin Combination Chemotherapy to Advanced Pancreatic Cancer

NCT01505413 ↗

Phase 2 Completed 33 enrolled Soonchunhyang University Hospital
NaSingle-groupOpen-labelTreatment

Summary

Erlotinib is an orally available, reversible tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR). Association of chemoresistance with the activity of certain tyrosine kinases (e.g. ErbB-1 and Src) has been described for pancreatic cancer and makes a strong case for combining gemcitabine with tyrosine kinase inhibitors. In a phase III trial, the addition of erlotinib to gemcitabine improved survival compared with gemcitabine alone in advanced pancreatic cancer (MJ Moor et al). Also, gemcitabine in combination with oxaliplatin is superior to gemcitabine alone in terms of progression free survival and response rate in one phase III trial (Louvet et al). Taken together, combining erlotinib with gemcitabine and oxaliplatin may further improve the overall survival and clinical benefit of advanced pancreatic cancer.

Timeline

Start
2011-01
Primary completion
2013-12
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 100 mg Oral
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 100 mg/m2 Intravenous