Bortezomib in Treating Patients With Unresectable Locally Advanced or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder
Condition: Adenocarcinoma of the Extrahepatic Bile Duct; Adenocarcinoma of the Gallbladder; Advanced Adult Primary Liver Cancer; Gastrointestinal Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer; Recurrent Extrahepatic Bile Duct Cancer; Recurrent Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer; Unresectable Gallbladder Cancer
MeSH terms: Adenocarcinoma; Liver Neoplasms; Gastrointestinal Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma; Recurrence
Intervention: bortezomib
Intervention description: Given IV
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well bortezomib works as first-line systemic therapy in
      treating patients with unresectable locally advanced or metastatic adenocarcinoma (cancer) of
      the bile duct or gallbladder. Bortezomib may stop the growth of tumor cells by blocking the
      enzymes necessary for their growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Absolute neutrophil count >= 1,500/mm3

          -  No psychiatric illness or social situation that would preclude study compliance

          -  Chemotherapy administered solely as a radiosensitizer or as adjuvant therapy and
             investigational or targeted therapies (i.e., inhibitors of the epidermal growth factor
             receptor) will not count toward the maximum of 2 prior regimens allowed

          -  Histologically or cytologically confirmed adenocarcinoma of the intrahepatic or
             extrahepatic bile duct or gallbladder:

               -  Locally advanced or metastatic disease

          -  At least 1 unidimensionally measurable lesion >=20 mm by conventional techniques OR >=
             10 mm by spiral CT scan

          -  Not amenable to curative surgical resection

          -  No known brain metastases

          -  Performance status:

               -  ECOG 0-2

          -  Life expectancy:

               -  More than 12 weeks

          -  Platelet count >= 100,000/mm3

          -  WBC >= 3,000/mm3

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN) [Note: Biliary shunting or
             stenting allowed to achieve the required bilirubin and transaminase levels]

          -  Bilirubin ≤ 1.5 times ULN [Note: Biliary shunting or stenting allowed to achieve the
             required bilirubin and transaminase levels]

          -  Creatinine within ULN OR Creatinine clearance >= 60 mL/min

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No symptomatic cardiac arrhythmia within the past 4 weeks

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No underlying neuropathy >= grade 2

          -  No history of allergic reaction to boron, mannitol, or bortezomib

          -  No active or ongoing infection

          -  No concurrent uncontrolled illness

          -  No medical or psychiatric condition that would preclude study participation

          -  No prophylactic granulocyte or platelet growth factors (filgrastim [G-CSF] or
             sargramostim [GM-CSF])

          -  Prior chemotherapy as a radiosensitizer (e.g., fluorouracil or gemcitabine) with
             radiotherapy is allowed as adjuvant therapy after resection for locally advanced
             disease provided there is evidence of disease progression

          -  No more than 2 prior chemotherapy regimens for locally advanced or metastatic disease

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent anticancer agents or therapies

          -  No other concurrent investigational agents