Phase 2 Study of GEMOX-T in Previously Untreated Patients With 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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 At any time, patients with progressive disease are withdrawn.
24 months (01/2011 and end of study 01/2013)
Yes
Kyu Taek Lee, Dr
Study Director
Soonchunhyang university Cheonan Hospital
Korea: Institutional Review Board
Yun-11349
NCT01505413
January 2011
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