The Study of Metastatic Pancreatic Adenocarcinoma

Phase I/II Trial of Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in Metastatic Pancreatic Adenocarcinoma

Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study

Phase I: 2~24 patients Phase II: Considering a design with p0 = 0.25 and p1 = 0.40 for which error is 0.10 and errors is 0.20, these constraints can be met with a two-stage Simon's design of 25 patients in the first stage and 27 patients in the second stage.

Inclusion criteria:

1. Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas (mPAC).
2. Patients must have no history of prior chemotherapy.
3. Patients with prior radiotherapy.
4. Patients' baseline ECOG performance status must be 2.
5. Patients' life expectancy must be 12 weeks or greater.
6. Patients' age must be 20 and 75.
7. Patients must have adequate bone marrow function.
8. Patients must have adequate liver and renal function.
9. All patients must be sign and give written informed consent.

Exclusion criteria:

1. Patients who have major abdominal surgery, radiotherapy.
2. Patients with central nervous system metastasis.
3. Patients with active infection.
4. Pregnant or breast-nursing women.
5. Patients with active cardiopulmonary disease.
6. Patients who have peripheral neuropathy > Grade I.
7. Patients who have serious concomitant systemic disorders.
8. Patients who have other prior or concurrent malignancy.
9. Patients who are under biologic treatment for their malignancy.