A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma
Condition: Biliary Tract Cancer
MeSH terms: Biliary Tract Neoplasms
Intervention: "Bevacizumab" in combination with "modified FOLFOX6".
Intervention description: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Biliary; Oxaliplatin; Bevacizumab

Summary:

      This study is for patients with biliary tract cancer that has spread and who are not
      candidates for surgical resection.

      The purpose of this research is to determine if bevacizumab can be safely administered with
      Modified FOLFOX 6 and find out what effects, good and/or bad, this type of treatment has on
      biliary cancer.

      In this study, a combination of chemotherapy, Modified FOLFOX6 and a biologic agent,
      bevacizumab will be tested.

      Subjects on this study will receive chemotherapy and bevacizumab every 2 weeks until their
      disease gets worse or they are unable to tolerate treatment.
    

Eligibility criteria:

        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