Bortezomib in Treating Patients With Unresectable Locally Advanced or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder
Adenocarcinoma of the Extrahepatic Bile Duct, Adenocarcinoma of the Gallbladder, Advanced Adult Primary Liver Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Extrahepatic Bile Duct
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
Sites / Locations
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.