APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat 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.

Inclusion criteria

• Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
• Life expectancy greater than or equal to 3 months.
• Patients must have measurable disease by RECIST.
• ECOG PS of 0, 1, or 2.
• Negative serum pregnancy test at the time of first dose for women of childbearing potential.

Exclusion criteria

• Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
• RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
• Evidence of New York Heart Association class III or greater cardiac disease.
• History of myocardial infarction, stroke, ventricular arrhythmia.
• Symptomatic central nervous system metastases.
• Pregnant or nursing women.
• Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
• History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months.
• Previous anti-EGFR kinase therapy.