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 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||Drug: bortezomib||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II and Pharmacodynamic Study of PS-341 in Patients With Unresectable or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder|
- Objective Response Rate [ Time Frame: Up to 1 year ]Objective Response Rate (ORR) was determined by best response on radiologic assessment (computed tomography or magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0.
- Time to Disease Progression [ Time Frame: Up to 1 year ]Time from initiation of therapy to first progressive disease.
- Overall Survival [ Time Frame: Up to 1 year ]The time from initiation of therapy to death or last follow-up.
- Correlation of the Degree of Proteasome Inhibition in Peripheral Blood With the Degree of Proteasome Inhibition in Tumor Specimens [ Time Frame: Once in the screening period (within 14 days of starting treatment) ]Proteasome inhibition compared between tumor specimens and peripheral blood. Sufficient tissue samples are required for this analysis.
- Correlation of Phenotypic Expression of NF-kB, p53, and Other Molecular Markers in Biliary Washings and Tumor Biopsies With Clinical Outcomes [ Time Frame: Once in the screening period (within 14 days of starting treatment) ]Evaluation of clinical outcomes with expression of molecular markers specified and others. Sufficient amount of biliary washings and tumor biopsies needed for analysis.
- Correlation of Treatment With Changes in Phenotypic Expression of Molecular Markers [ Time Frame: Duration of study treatment ]Phenotypic expression of molecular markers before and after study treatment
|Study Start Date:||January 2004|
|Study Completion Date:||April 2010|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
I. Determine the objective response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the bile duct or gallbladder treated with bortezomib.
I. Determine the time to disease progression in patients treated with this drug.
II. Determine the overall survival of patients treated with this drug. III. Correlate the degree of proteasome inhibition in peripheral blood with degree of proteasome inhibition in tumor specimens of patients treated with this drug.
IV. Correlate phenotypic expression of NF-kB, p53, and other molecular markers in biliary washings and tumor biopsies with clinical outcomes in patients treated with this drug.
V. Correlate treatment with this drug with changes in phenotypic expression of molecular markers in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085410
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Principal Investigator:||Steven Cohen||Fox Chase Cancer Center|