| Exclusion Criteria: | 1) Patients with history of myocardial infarction, transient ischemic attack (TIA), stroke, pulmonary embolism, or history of deep vein thrombosis within the preceding 12 months.
2) Patients with major risk of bleeding, such as active brain metastases. Patients with controlled or small brain metastases will be eligible based on clinical assessment of the actual bleeding risk.
3) Patients with history of any major surgical procedure within the preceding 28 days.
4) Patients with baseline blood pressure >/= 140 systolic or >/= 90 diastolic.
5) Patients with nephrotic syndrome (proteinuria > 2 grams per 24 hours)
6) History of other malignancy, unless it is clinically non-threatening (such as non-melanoma skin cancer) or controlled for 2 years prior to study entry.
7) Prior treatment with gemcitabine, capecitabine, or any fluoropyrimidine.
8) Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU.
9) Any concurrent chemotherapy or radiotherapy.
10) Lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
11) Clinically significant cardiac disease not well controlled with medication, such as symptomatic coronary artery disease, congestive heart failure, and cardiac arrhythmias.
12) Serious concurrent infections or other serious medical conditions, including uncontrolled diabetes.
13) Any serious non-healing wound, ulcer, or active bone fracture.
14) Any concurrent coumadin therapy. Patients who were previously on coumadin maintenance may switch to aspirin or low-molecular-weight heparin.
15) Patients who have had an organ allograft.
16) Unwillingness to give written informed consent. |