APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer

Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas that is
locally advanced or metastatic.

2. Life expectancy greater than or equal to 3 months.

3. Patients must have measurable disease by RECIST.

4. ECOG PS of 0, 1, or 2.

5. Negative serum pregnancy test at the time of first dose for women of childbearing
potential.

Exclusion Criteria:

1. Previous chemotherapy as primary treatment for locally advanced or metastatic
pancreatic cancer(stage 3 T3 and T4, and all stage 4).

2. RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational
agents within 4 weeks of initiating study treatment.

3. Evidence of New York Heart Association class III or greater cardiac disease.

4. History of myocardial infarction, stroke, ventricular arrhythmia.

5. Symptomatic central nervous system metastases.

6. Pregnant or nursing women.

7. Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides,
aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).

8. History of upper gastrointestinal bleeding, ulceration or perforation. History of
lower GI bleeding, ulceration, or perforation within 12 months.

9. Previous anti-EGFR kinase therapy.