Gemcitabine and S-1 for Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Inclusion criteria * Adenocarcinoma of the pancreas that is already or will be histologically or cytologically proven. * Patients must have either locally advanced (unresectable) or metastatic disease. * Radiographically measurable disease is not required. * No prior therapy for advanced pancreatic cancer. Treatment given in the adjuvant setting (radiation and/or chemotherapy, given either concurrently or systemically) does not count as prior therapy as long as progressive disease occurs \> 6 months following completion of treatment. * Greater than or equal to 18 years of age. * ECOG performance status of 0 or 1 (See Appendix D). * Laboratory criteria: * ANC \> 1500/µL * Platelet count \> 100,000/µL * Hemoglobin \> 9 g/dL (may be transfused or receive epoetin alfa to maintain or exceed this level) * INR \< 1.5 (except those subjects who are receiving full-dose warfarin * Total bilirubin \< 2.0 mg/dL * AST or ALT \< 5 times upper limit of normal for subjects with documented liver metastases; \< 2.5 times the upper limit of normal for subjects without evidence of liver metastases * Serum creatinine \< 2.0 mg/dL * Serum CA19-9 \> 2X upper limits of normal. * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. * Women or men of reproductive potential must agree to use an effective contraceptive method during treatment and for 6 months afterwards. Exclus…