Erlotinib is an orally available, reversible tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR). Association of chemoresistance with the activity of certain tyrosine kinases (e.g. ErbB-1 and Src) has been described for pancreatic cancer and makes a strong case for combining gemcitabine with tyrosine kinase inhibitors. In a phase III trial, the addition of erlotinib to gemcitabine improved survival compared with gemcitabine alone in advanced pancreatic cancer (MJ Moor et al). Also, gemcitabine in combination with oxaliplatin is superior to gemcitabine alone in terms of progression free survival and response rate in one phase III trial (Louvet et al). Taken together, combining erlotinib with gemcitabine and oxaliplatin may further improve the overall survival and clinical benefit of advanced pancreatic cancer.
Open, uncontrolled, multicenter, phase II study This study will enroll previous chemo-naïve patients with locally advanced unresectable or metastatic pancreatic cancer. Study regimen: * Erlotinib 100 mg po qd daily AND * Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1 * Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2 Every 2 weeks Each two weeks is a cycle. If at end of 12 cycles response continues, will administer Gemcitabine and erlotinib until progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Erlotinib 100 mg po qd daily
Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1
Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Response rate
Responses are assessed every 2 cycles according to RECIST; the imaging tests are performed in a week preceding the corresponding cycles, and can also be repeated at any other time if clinically indicated, for example, to confirm disease progression. At any time, patients with progressive disease are withdrawn.
Time frame: 24 months (01/2011 and end of study 01/2013)
disease control rate(SD,PR,CR)
Responses are assessed every 2 cycles according to RECIST; the imaging tests are performed in a week preceding the corresponding cycles, and can also be repeated at any other time if clinically indicated, for example, to confirm disease progression. At any time, patients with progressive disease are withdrawn.
Time frame: 24 months (01/2011 and end of study 01/2013)
Overall survival
Time frame: 1 year
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