Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers
Condition: Stage III Intrahepatic Cholangiocarcinoma AJCC v7; Stage IIIA Gallbladder Cancer AJCC v7; Stage IIIB Gallbladder Cancer AJCC v7; Stage IVA Gallbladder Cancer AJCC v7; Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7; Stage IVB Gallbladder Cancer AJCC v7; Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7; Unresectable Extrahepatic Bile Duct Carcinoma; Unresectable Gallbladder Carcinoma
MeSH terms: Carcinoma; Cholangiocarcinoma; Gallbladder Neoplasms; Carcinoma, Ductal
Intervention: Cisplatin; Gemcitabine Hydrochloride; Laboratory Biomarker Analysis; Nab-paclitaxel
Intervention description: Given IV; Given IV; Correlative studies; Given IV
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Cisplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel
      (paclitaxel albumin-stabilized nanoparticle formulation) work in treating patients with
      biliary cancers (which includes the gallbladder and bile ducts inside and outside the liver)
      that have spread to other places in the body and usually cannot be cured or controlled with
      treatment. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and
      paclitaxel albumin-stabilized nanoparticle formulation, 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. Giving more than one drug (combination chemotherapy) may kill
      more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have histologically or cytologically confirmed intrahepatic
             cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer or may
             undergo a repeat biopsy for histologic confirmation if pre-existing biopsy is not
             sufficient for diagnosis

          -  Metastatic or unresectable disease documented on diagnostic imaging studies

          -  May not have received prior chemotherapy; if patient has received prior adjuvant
             therapy, must be > 6 months from treatment

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

          -  Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

          -  Platelets >= 100,000/ul

          -  Hemoglobin > 9.0 g/dL

          -  Total bilirubin =< 1.5 mg/dL (in patients with known Gilbert's syndrome direct
             bilirubin =< 1.5 x upper limit of normal [ULN] will be used as organ function
             criteria, instead of total bilirubin)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = < 5 x ULN

          -  Creatinine =< 1.5 gm/dL

          -  Negative serum or urine pregnancy test in women with childbearing potential (WOCBP)
             defined as not post-menopausal for 12 months or no previous surgical sterilization,
             within one week prior to initiation of treatment; WOCBP must be using an adequate
             method of contraception to avoid pregnancy throughout the study and for up to 12 weeks
             after the last dose of study drug to minimize the risk of pregnancy

          -  A male subject of fathering potential must use an adequate method of contraception to
             avoid conception throughout the study and for up to 12 weeks after the last dose of
             study drug to minimize the risk of pregnancy; if the partner is pregnant or
             breastfeeding, the subject must use a condom

          -  Patients must sign an informed consent and authorization indicating that they are
             aware of the investigational nature of this study and the known risks involved

        Exclusion Criteria:

          -  Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse
             Events (CTCAE) 4.0; in CTCAE version 4.0 grade 2 sensory neuropathy is defined as
             "moderate symptoms; limiting instrumental activities of daily living (ADLs)"

          -  Concurrent severe and/or uncontrolled medical conditions which could compromise
             participation in the study such as unstable angina, myocardial infarction within 6
             months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or
             uncontrolled infection

          -  Pregnancy (positive pregnancy test) or lactation

          -  Known central nervous system (CNS) disease, except for treated brain metastasis;
             treated brain metastases are defined as having no evidence of progression or
             hemorrhage after treatment and no ongoing requirement for dexamethasone, as
             ascertained by clinical examination and brain imaging (magnetic resonance imaging
             [MRI] or computed tomography [CT]) during the screening period; anticonvulsants
             (stable dose) are allowed; treatment for brain metastases may include whole brain
             radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator [LINAC], or
             equivalent) or a combination as deemed appropriate by the treating physician; patients
             with CNS metastases treated by neurosurgical resection or brain biopsy performed
             within 3 months prior to day 1 will be excluded