Metastatic Pancreatic Cancer
Conditions
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.
Interventions
DRUGErlotinib
Erlotinib 100 mg 1# PO qd till disease progression
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate | eight weeks |
Secondary
| Measure | Time frame |
|---|---|
| response rate | eight weeks |
| overall survival | one day |
| progression-free survival | one day |
Countries
Taiwan
Contacts
Primary ContactChung-Pin Li, MD
Outcome results
None listed