Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Inclusion Criteria:

• 18 years of age or older
• At most one prior chemotherapy regimen for unresectable or metastatic disease. Any adjuvant chemotherapy must have been completed more than 12 months prior to beginning protocol therapy
• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• At least one measurable lesion according to RECIST criteria that has not been irradiated
• Adequate laboratory parameters as outlined in protocol
• Anticoagulation with coumadin is permitted, but PT/INR must be monitored closely, given the drug-drug interaction between coumadin and capecitabine
• Negative serum pregnancy test within 14 days prior to registration

Exclusion Criteria:

• Pregnant or lactating women
• Life expectancy < 3 months
• Serious, uncontrolled, concurrent infection(s)
• Any prior oxaliplatin or fluoropyrimidine therapy
• More than one prior chemotherapy regimen for unresectable or metastatic disease
• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or platinum compounds
• Any active second malignancy
• Clinically significant cardiac disease or myocardial infarction within the last 12 months
• Evidence of CNS metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability
• Other serious uncontrolled medical conditions
• Major surgery within 4 weeks of the start of study treatment, without complete recovery
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
• Known, existing uncontrolled coagulopathy