Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma

The purpose of this study is to test the effectiveness and safety of the drug combination of gemcitabine and capecitabine (Xeloda) in patients with advanced pancreatic cancer.

Inclusion Criteria:

• Metastatic or unresectable pancreatic cancer
• No prior chemotherapy except radiation-sensitizing doses of 5-FU
• No radiotherapy less than 4 weeks prior to the start of the study

Exclusion Criteria:

• Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU
• Moderate to severe renal impairment
• Uncontrolled diabetes
• Inability to swallow tablets