This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
109
Gemcitabine: per package insert.
placebo: 100 mg tablets, 400 mg/day
Erlotinib - per package insert.
Progression Free Survival
Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
Time frame: Randomization then every other cycle
Overall Survival
Time frame: Randomization then every other cycle
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apricoxib: 100mg tablets, given orally
Arizona Clinical Research Center
Tucson, Arizona, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Southbay Oncology Hematology Partners
Campbell, California, United States
Bay Area Cancer Research Group, LLC
Concord, California, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States
North America Research Institute
San Dimas, California, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
Oncology Associates of Bridgeport
Trumball, Connecticut, United States
Hematology Oncology Associates
Lake Worth, Florida, United States
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, United States
...and 29 more locations