TAS-102 in Treating Advanced Biliary Tract Cancers
Condition: Cholangiocarcinoma; Stage III Gallbladder Cancer AJCC v7; Stage IIIA Gallbladder Cancer AJCC v7; Stage IIIB Gallbladder Cancer AJCC v7; Stage IV Gallbladder Cancer AJCC v7; Stage IVA Gallbladder Cancer AJCC v7; Stage IVB Gallbladder Cancer AJCC v7
MeSH terms: Cholangiocarcinoma; Biliary Tract Neoplasms; Gallbladder Neoplasms
Intervention: Laboratory Biomarker Analysis; Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102
Intervention description: Correlative studies; Given PO
Intervention MeSH terms: Trifluridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well trifluridine/tipiracil hydrochloride combination agent
      TAS-102 (TAS-102) works in treating participants with biliary tract cancers that have spread
      to other places in the body. Drugs used in the chemotherapy, such as trifluridine/tipiracil
      hydrochloride combination agent TAS-102, work in different ways to stop the growth of tumor
      cells, either by killing the cells, by stopping them from dividing, or by stopping them from
      spreading.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of advanced biliary tract cancers including cancers
             originating in gallbladder who have received at least one line of systemic anticancer
             therapy;

               -  Note: Patients who have either progressed or intolerant to the prior therapy can
                  be included in this study

          -  Measurable disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

          -  Absolute neutrophil count (ANC) >= 1500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN)

          -  Aspartate transaminase (AST) or alanine transaminase (ALT) =< 3 x ULN

          -  Creatinine =< 1.5 x ULN

          -  Negative pregnancy test done =< 7 days prior to registration, for persons of
             childbearing potential only

          -  Provide written informed consent

          -  Willing to return to enrolling institution for follow-up (during the active monitoring
             phase of the study)

          -  Willing to provide blood samples for correlative research purposes

        Exclusion Criteria:

          -  Any of the following:

               -  Pregnant persons

               -  Nursing persons

               -  Persons of childbearing potential who are unwilling to employ adequate
                  contraception for at least 3 months after the last dose of the study drug

          -  Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
             of the investigator, would make the patient inappropriate for entry into this study or
             interfere significantly with the proper assessment of safety and toxicity of the
             prescribed regimens

          -  Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)
             positive and currently receiving antiretroviral therapy; NOTE: patients known to be
             HIV positive, but without clinical evidence of an immunocompromised state, are
             eligible for this trial

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Receiving any other investigational agent which would be considered as a treatment for
             the primary neoplasm =< 21 days prior to registration

          -  Receiving any anticancer therapy for biliary tract cancer =< 21 days prior to
             registration

          -  Other active malignancy requiring treatment in =< 6 months prior to registration;
             EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if
             there is a history of prior malignancy, they must not be receiving other specific
             treatment for their cancer

          -  History of myocardial infarction =< 6 months prior to registration, or congestive
             heart failure requiring use of ongoing maintenance therapy for life-threatening
             ventricular arrhythmias