Status:
TERMINATED
Bortezomib in Treating Patients With Unresectable Locally Advanced or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Extrahepatic Bile Duct
Adenocarcinoma of the Gallbladder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the bile duct or gallbladder treated with bortezomib. SECO...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00085410
Start Date
January 1 2004
End Date
April 1 2010
Last Update
July 2 2017
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497