A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma

This is an interventional treatment trial for Biliary Tract Cancer focused on measuring Biliary, Oxaliplatin, Bevacizumab Read More

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of non-resectable adenocarcinoma of the biliary tract, including carcinomas of the gallbladder, the intrahepatic or extrahepatic biliary tract, and ampullary cancer
• Measurable or evaluable disease
• Locally advanced disease that is inoperable ot patients who have had disease recurrence after curative surgical attempt
• Ambulatory with an ECOG performance status of 0-1
• Adequate organ and marrow function
• Must agree to avoid pregnancy prior to study entry and throughout the duration of study participation
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Any prior chemotherapy
• Patients who are receiving other investigational agents
• Patients who have received radiotherapy to more than 25% of their bone marrow for any reason
• Peripheral neuropathy >/= 2
• Known brain metastases, uncontrolled seizure disorder, encephalitis
• Prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension,unstable angina, congestive heart failure of New York Heart Association (NYHA) class 2 or greater, left ventricular ejection fraction less than 50%, clinically significant vascular disease, serious cardiac arrhythmia requiring medication, cardiomyopathy
• History of myocardial infarction, unstable angina or stroke/transient ischemic attack (TIA) within 6 months
• History of allergy to oxaliplatin, 5-fluoruracil (5-FU), Leucovorin, or Bevacizumab
• History of intra-abdominal abscess within 4 weeks of study entry, abdominal fistula, gastrointestinal perforation, active peptic ulcer disease, or inflammatory bowel disease
• Evidence of bleeding diathesis or coagulopathy
• Serious non-healing wound, ulcer, or bone fracture
• Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks of study entry or anticipation of need for major surgery during the course of the study
• Minor surgical procedures such as core biopsies within 7 days before enrollment, chemotherapy port placement within 24 hours
• Patients on full-dose anticoagulants who have out of range international normalized ratio (INR) or active bleeding
• Concurrent malignancy unless the subject has been curatively treated and disease free for >/= 2 years or the cancer was non-melanoma skin cancer or early cervical cancer
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
• Known HIV or Hepatitis B or C
• Life expectancy less than 12 weeks
• Pregnant or nursing women