The Role of EGFR Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib
- Registration Number
- NCT01608841
- Lead Sponsor
- Taipei Veterans General Hospital, Taiwan
- 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.
- Detailed Description
The influence of EGFR mutations on the efficacy of treatment with and without erlotinib in metastatic pancreatic cancer is to be determined.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 88
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Gemcitabine plus erlotinib Erlotinib -
- Primary Outcome Measures
Name Time Method disease control rate eight weeks
- Secondary Outcome Measures
Name Time Method response rate eight weeks overall survival one day progression-free survival one day
Trial Locations
- Locations (1)
Division of Gastroenterology, Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan