The Role of EGFR Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib
Metastatic Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Study Type
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Erlotinib
Type: Drug
Overall Status
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.
Detailed Description
The influence of EGFR mutations on the efficacy of treatment with and without erlotinib in metastatic pancreatic cancer is to be determined.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Division of Gastroenterology, Taipei Veterans General Hospital
Taipei, Taiwan
Status: Recruiting
Contact: Chung-Pin Li, MD - +886-2-28757506 -
Start Date
July 2005
Completion Date
October 2015
Taipei Veterans General Hospital, Taiwan
Taipei Veterans General Hospital, Taiwan
Record processing date processed this data on July 28, 2015 page