Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer
Condition: Stage II Gallbladder Cancer; Stage IIIA Gallbladder Cancer; Stage IIIB Gallbladder Cancer; Stage IVA Gallbladder Cancer; Stage IVB Gallbladder Cancer
MeSH terms: Gallbladder Neoplasms
Intervention: triapine; gemcitabine
Intervention description: Given IV; Given IV
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase II trial is studying how well giving 3-AP together with gemcitabine works in
      treating patients with unresectable or metastatic bile duct or gallbladder cancer. Drugs used
      in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells
      from dividing so they stop growing or die. 3-AP may help gemcitabine kill more cancer cells
      by making them more sensitive to the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the biliary ducts that is
             unresectable and/or metastatic; this can include unresectable or metastatic carcinomas
             of the Ampulla of Vater. In addition, unresectable or metastatic gall bladder
             carcinoma will be allowed

          -  Measurable disease

          -  No prior chemotherapy

          -  Life expectancy of greater than 3 months

          -  ECOG performance status =< 2 (Karnofsky >= 60%)

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Creatinine within normal institutional limits

          -  Patients may have mildly abnormal liver function defined as a total bilirubin > ULN
             and =< 3x the institutional upper limits of normal (includes CTCAE v.3 grades 1-2
             hyperbilirubinemia)

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients may not be receiving any other investigational agents

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to Triapine or gemcitabine

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
             arrhythmia

          -  Uncontrolled pulmonary disease including asthma, chronic bronchitis and COPD or with
             requirements for chronic oxygen use

          -  Pregnant or lactating women

          -  HIV infection

          -  Patients with G6PD deficiency will be excluded in view of the potential for
             methemoglobinemia

          -  Psychiatric illness/social situations that would limit compliance with study
             requirements