NCT00482625

Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This phase II trial is studying how well erlotinib hydrochloride works in treating patients with pancreatic cancer that can be removed by surgery

Detailed description

PRIMARY OBJECTIVES: I. To test the hypothesis that the activated epidermal growth factor receptor (EGFR) signal transduction biomarker Mucin 5AC (MUC5AC) protein expression within intraductal pancreatic mucinous neoplasm (IPMN) lesions will have greater than zero absolute mean decrease from baseline comparing pre and post 21-42 days of Erlotinib (erlotinib hydrochloride) administration at 100mg orally (PO) once daily (QD). SECONDARY OBJECTIVES: I. To test the hypothesis that other correlative IPMN EGF inducible biomarkers will have greater than zero absolute mean decrease from baseline pre and post Erlotinib 100mg PO QD therapy. II. Safety of Erlotinib treatment. III. To determine Erlotinib pharmacokinetic concentration in plasma and pancreatic tissue at the 100mg/day dose up to 42 days of therapy. OUTLINE: Patients receive erlotinib hydrochloride PO QD for 21-42 days in the absence of disease progression or unacceptable toxicity. Patients then undergo to pancreatectomy. After completion of study treatment, patients are followed up at 4-20 weeks.

Conditions

• Intraductal Papillary Mucinous Neoplasm of the Pancreas
• Recurrent Pancreatic Cancer
• Stage IA Pancreatic Cancer
• Stage IB Pancreatic Cancer
• Stage IIA Pancreatic Cancer
• Stage IIB Pancreatic Cancer
• Stage III Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given PO
PROCEDURE	conventional surgery	Undergo pancreatectomy
OTHER	immunohistochemistry staining method	Correlative studies
GENETIC	protein expression analysis	Correlative studies
PROCEDURE	biopsy	Correlative studies
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-02-01
• Completion: 2013-09-01
• First posted: 2007-06-05
• Last updated: 2014-10-16
• Results posted: 2014-05-19

Locations

1 site across 1 country: United States