Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer
Condition: Biliary Tract Cancer; Gallbladder Adenocarcinoma
MeSH terms: Biliary Tract Neoplasms; Gallbladder Neoplasms
Intervention: Bevacizumab; Gemcitabine; Oxaliplatin
Intervention description: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.; Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.; Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Intervention MeSH terms: Bevacizumab; Gemcitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Avastin; GEMOX

Summary:

      The purposes of this study are to test the safety of bevacizumab when given in combination
      with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has
      on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or
      stop cell growth in tumors by decreasing the blood supply to the tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, locally unresectable or metastatic biliary tract or
             gallbladder adenocarcinoma. Patients must have at least one measurable lesion outside
             prior radiation field.

          -  Zero to one prior chemotherapy for biliary tract or gallbladder cancer

          -  Age > 18 years

          -  ECOG performance status 0-2

          -  Life expectancy > 12 weeks

          -  Adequate organ and bone marrow function

        Exclusion Criteria:

          -  Chemotherapy within past 3 weeks of initiation of therapy

          -  Pregnant or lactating women

          -  Clinically apparent central nervous system metastases or carcinomatous meningitis

          -  Biliary obstruction with inadequate drainage and total bilirubin > 2.5 mg/dL

          -  Concurrent malignancy of any site, except limited basal cell carcinoma or squamous
             cell carcinoma of the skin or carcinoma in situ of the cervix

          -  Uncontrolled serious medical or psychiatric illness

          -  Pre-existing peripheral neuropathy of grade 2 or greater severity according to the
             Common Terminology Criteria of the NCI (version 3.0)

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study

          -  Blood pressure of > 150/100 mmHg

          -  Unstable angina

          -  NYHA Grade II or greater congestive heart failure

          -  History of myocardial infarction or stroke within 6 months

          -  Clinically significant peripheral vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Major surgical procedure, open biopsy, or significant traumatic injury with 28 days
             prior to Day 1, anticipation of need for major surgical procedure during the course of
             the study

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to day 1

          -  Serious, non-healing wound, ulcer, or bone fracture