Phase II and Pharmacodynamic Study of PS-341 in Patients With Unresectable or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with complete or partial response, evaluated using the international criteria proposed by the RECIST Committee
Up to 1 year
Fox Chase Cancer Center
United States: Food and Drug Administration
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|