Locally Advanced or Metastatic Pancreatic Adenocarcinoma

To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria)

Secondary objectives:

Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer

Inclusion criteria

• Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas.
• Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination.
• Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible.
• Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
• Baseline ECOG performance status is 2.
• Patients have life expectancy of at least 12 weeks.
• Patients have age 70 years.
• Patients have adequate organ function.
• Patients with biliary obstruction which is adequate drained before enrollment are eligible.
• Patients agree to have an indwelling venous catheter implanted.
• Women or men of reproductive potential should agree to use an effective contraceptive method.
• All patients must be informed of the investigational nature of this study and must sign written informed consents.

Exclusion criteria

• Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
• Patients with metastatic lesion in central nervous system.
• Patients with active infection.
• Patients with active cardiopulmonary disease or history of ischemic heart disease.
• Patients who have peripheral neuropathy > grade I of any etiology.
• Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
• Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.