Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery
Condition: Adenocarcinoma of the Extrahepatic Bile Duct; Adenocarcinoma of the Gallbladder; Malignant Neoplasm; Recurrent Extrahepatic Bile Duct Cancer; Recurrent Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer; Unresectable Gallbladder Cancer
MeSH terms: Adenocarcinoma; Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma; Recurrence
Intervention: trastuzumab; laboratory biomarker analysis
Intervention description: For HER-2/neu positive biopsies, trastuzumab was administered intravenously, once every 3 weeks, at a loading first dose at 8 mg/kg over 90 minutes, and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose.; Correlative studies
Intervention MeSH terms: Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well trastuzumab works in treating patients with locally
      advanced or metastatic gallbladder cancer or bile duct cancer that cannot be removed by
      surgery. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them
    

Eligibility criteria:

        Criteria:

          -  Adenocarcinoma of the gallbladder

          -  Recurrent extrahepatic bile duct cancer

          -  Recurrent gallbladder cancer

          -  Unresectable extrahepatic bile duct cancer

          -  Adenocarcinoma of the extrahepatic bile duct

          -  Unresectable gallbladder cancer

          -  Prior surgery and radiotherapy allowed

          -  At least 28 days since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C)
             and recovered

          -  No other concurrent investigational agents, chemotherapy, radiotherapy, or hormonal
             therapy

          -  Concurrent hormones administered for nondisease-related conditions (e.g., insulin for
             diabetes) allowed

          -  No concurrent corticosteroids or anticonvulsants

          -  Concurrent steroids administered for antiemesis, adrenal failure, or septic shock
             allowed

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  Histologically or cytologically confirmed adenocarcinoma of the gallbladder or bile
             duct, meeting all of the following criteria: locally advanced or metastatic disease
             that is unresectable

          -  Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by
             conventional techniques or >= 10 mm by spiral computed tomography (CT) scan

          -  Tumor that recurs within a previously irradiated field is considered measurable
             disease if recurrence is documented and measurable by Response Evaluation Criteria in
             Solid Tumors (RECIST) criteria

          -  Tumor must be Her2/neu positive by Fluorescence in situ hybridization (FISH)testing

          -  No symptomatic brain metastases

          -  The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky
             PS 60-100%

          -  Absolute neutrophil count (ANC) >= 1,500/mm^3

          -  Fertile patients must use effective contraception prior to, during, and for >= 3
             months after completion of study treatment

          -  Creatinine =< 2 times upper limits of normal (ULN) OR creatinine clearance >= 60
             mL/min

          -  No other active malignancy

          -  Left Ventricular Ejection Fraction (LVEF) >= 50%

          -  No concurrent uncontrolled illness

          -  No ongoing or active infection requiring systemic IV antibiotics on day 1 of treatment

          -  No symptomatic New York Heart Association class III-IV congestive heart failure

          -  No unstable angina pectoris

          -  No unstable cardiac arrhythmia requiring medication

          -  No more than 1 prior systemic chemotherapy regimen

          -  White Blood Count (WBC) >= 3,000/mm^3

          -  Platelet count >= 40,000/mm^3

          -  Bilirubin =< 4 mg/dL

          -  Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =< 5 times upper
             limit of normal (ULN)

          -  Not pregnant or nursing

          -  Negative pregnancy test