Bortezomib in Treating Patients With Unresectable Locally Advanced or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib

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