A phase II trial of the proteasome inhibitor bortezomib in patients with advanced biliary tract cancers.

ABSTRACT:

Background

Patients with advanced biliary tract cancers have limited therapeutic options. Preclinical data suggest that proteasome inhibition may be an effective therapeutic strategy. We thus evaluated the clinical efficacy of bortezomib in advanced biliary tract cancers.

Patients and methods

Patients with locally advanced or metastatic cholangiocarcinoma or gallbladder adenocarcinoma who had received 0 to 2 previous therapies received bortezomib 1.3 mg/m(2) on days 1, 4, 8, and 11 of a 21-day cycle. The primary end point was objective response rate. A Simon 2-stage design was used (null response rate of < 5% and response rate of ≥ 20% of interest).

Results

Twenty patients enrolled (bile duct/gallbladder cancer [14/6] and previous treatments 0/1/2 [10/6/3]). The trial

SUBMITTER: Denlinger CS 

PROVIDER: S-EPMC4189831 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature