Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater

Exclusion criteria

• . Patients with prior exposure to platinum therapy are excluded. Patients who have received prior chemotherapy for metastatic disease are excluded.
• . Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• . Patients may not be receiving any other investigational agents nor have received any investigational drug 30 days prior to enrollment.
• . Patients with known brain metastases are excluded from this clinical trial because of their poor prognosis and their risk for progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• . Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation. Prior surgical therapy affecting absorption.
• . Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• . Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with XELOX. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
• . Patients with extensive symptomatic fibrosis of the lungs.