Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer

Inclusion Criteria

• Histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
• Have measurable disease.
• Male or non-pregnant and non-lactating female of age >18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 . ECOG 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ECOG 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature
• Subjects must have adequate organ and marrow function.
• Must use acceptable form of birth control prior to study and and for the duration of study.
• Willing and able to comply with study procedures

Exclusion Criteria

• Patient who have had any prior chemotherapy within 5 years of enrollment.
• Patient who have had radiotherapy for pancreatic cancer.
• Age ≥ 76 years
• Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
• Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study.
• Patient who has known brain metastases.
• Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, taxotere, xeloda, cisplatin, or irinotecan.
• Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patient who has serious medical risk factors involving any of the major organ systems.
• Patient who has known history of infection with HIV, hepatitis B, or hepatitis C.
• Pregnant or breast feeding.
• Patient is unwilling or unable to comply with study procedures
• Patient with clinically significant wound