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The Role of EGFR Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan Identifier:
First received: May 28, 2012
Last updated: February 14, 2015
Last verified: February 2015
The purpose of this study is to investigate the influence of epidermal growth factor receptor mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic cancer.

Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Epidermal Growth Factor Receptor (EGFR) Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib

Resource links provided by NLM:

Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • disease control rate [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • response rate [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: one day ] [ Designated as safety issue: Yes ]
  • progression-free survival [ Time Frame: one day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: July 2005
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Gemcitabine
Experimental: Gemcitabine plus erlotinib Drug: Erlotinib
Erlotinib 100 mg 1# PO qd till disease progression
Other Name: Tarceva

Detailed Description:
The influence of EGFR mutations on the efficacy of treatment with and without erlotinib in metastatic pancreatic cancer is to be determined.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • metastatic chemotherapy-naïve pancreatic cancer patients
  • histologically confirmed
  • adequate samples for analysis
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 2
  • absolute neutrophil count (ANC) >= 1,500/mm3
  • platelet count >= 100,000/mm3
  • serum creatinine <= 1.5 mg/dL
  • aspartate aminotransferase (AST)
  • alanine aminotransferase (ALT) < 5 times the upper limit of normal

Exclusion Criteria:

  • absence of any other malignancy or serious medical or psychological illness that would preclude informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01608841

Contact: Chung-Pin Li, MD +886-2-28757506

Division of Gastroenterology, Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Chung-Pin Li, MD    +886-2-28757506   
Principal Investigator: Chung-Pin Li, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Principal Investigator: Chung-Pin Li, MD, PhD Taipei Veterans General Hospital, Taiwan
Study Director: Yee Chao, MD,PhD Taipei Veterans General Hospital, Taiwan
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: vghtpe user, Attending Physician, Taipei Veterans General Hospital, Taiwan Identifier: NCT01608841     History of Changes
Other Study ID Numbers: 98-01-34A 
Study First Received: May 28, 2012
Last Updated: February 14, 2015
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors processed this record on December 09, 2016