The Role of EGFR Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib
The Role of Epidermal Growth Factor Receptor (EGFR) Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib
1 other identifier
interventional
88
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 28, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFebruary 18, 2015
February 1, 2015
10.3 years
May 28, 2012
February 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
disease control rate
eight weeks
Secondary Outcomes (3)
response rate
eight weeks
overall survival
one day
progression-free survival
one day
Study Arms (2)
Gemcitabine
NO INTERVENTIONGemcitabine plus erlotinib
EXPERIMENTALInterventions
Erlotinib 100 mg 1# PO qd till disease progression
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- absence of any other malignancy or serious medical or psychological illness that would preclude informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Gastroenterology, Taipei Veterans General Hospital
Taipei, Taiwan, 11217, Taiwan
Related Publications (1)
Wang JP, Wu CY, Yeh YC, Shyr YM, Wu YY, Kuo CY, Hung YP, Chen MH, Lee WP, Luo JC, Chao Y, Li CP. Erlotinib is effective in pancreatic cancer with epidermal growth factor receptor mutations: a randomized, open-label, prospective trial. Oncotarget. 2015 Jul 20;6(20):18162-73. doi: 10.18632/oncotarget.4216.
PMID: 26046796DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chung-Pin Li, MD, PhD
Taipei Veterans General Hospital, Taiwan
- STUDY DIRECTOR
Yee Chao, MD,PhD
Taipei Veterans General Hospital, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
May 28, 2012
First Posted
May 31, 2012
Study Start
July 1, 2005
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
February 18, 2015
Record last verified: 2015-02