A Study of Gemcitabine, Capecitabine and Bevacizumab to Treat Cancer of the Gall Bladder or Bile Ducts

Exclusion Criteria

• •Subjects meeting any of the following criteria are ineligible for study entry:
• •Compromised renal or hepatic function.
• •Screening clinical laboratory values INR ≥ 1.5 (except those subjects who are receiving full-dose warfarin)
• •Hemoglobin \< 9 gm/dL (may be transfused or receive epoetin alfa (e.g., Epogen@) to maintain or exceed this level).
• •Bevacizumab risk factors: History of serious systemic disease, including uncontrolled hypertension (blood pressure of greater than 160/110 mmHg on medication), prior history of hypertensive crisis or hypertensive encephalopathy, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or clinically significant peripheral vascular disease (Grade II or greater).
• •Presence of central nervous system or brain metastases.
• •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations or core biopsies within 7 days prior to Day O.
• •Pregnancy (positive pregnancy test) or lactation.
• •24 hour urine creatinine clearance \< 50 ml/min or urine protein/creatinine ratio greater than or equal to 1.0 at screening.
• •Serious, nonhealing wound, ulcer, or bone fracture.
• •Evidence of bleeding diathesis or coagu1opathy.
• •Recent (less than or equal to six months) arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI).
• •Inability to comply with study and/or follow-up procedures.
• •Patients with known duodenal or gastric wall involvement should be excluded.
• •Patients with suspected involvement of stomach or duodenum should have screening endoscopies to exclude the same prior to therapy.
• •Patients with esophageal or gastric varices.
• •Patients with recent hemoptysis (within 1 week).