drugset / Trial / NCT02154737

Gemcitabine and Pulse Dose Erlotinib in Second Line Treatment of Advanced Pancreatic Cancer

NCT02154737 ↗

Phase 1 Completed 24 enrolled Tony Reid, M.D., Ph.D. Genentech, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to see whether an altered schedule of giving erlotinib in combination with gemcitabine will be safe and might improve the results of the treatment for advanced cancer of the pancreas. Gemcitabine and erlotinib are commercially available. Gemcitabine is FDA approved as first-line treatment for patients with locally advanced, unresectable or metastatic cancer of the pancreas. Erlotinib is FDA approved in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer. The FDA recommended dose for erlotinib is 100 mg daily. This study will investigate the experimental administration of higher doses of erlotinib given for only three days twice a month, a schedule called "pulse dosing".

Timeline

Start
2013-07
Primary completion
2020-09-03
Completion
2020-09-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 750 mg Oral
Subject Erlotinib Small molecule 1000 mg Oral
Subject Erlotinib Small molecule 1250 mg Oral
Subject Erlotinib Small molecule 1500 mg Oral
Subject Erlotinib Small molecule 1750 mg Oral
Subject Erlotinib Small molecule 2000 mg Oral
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous