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

Phase 2 Terminated 20 enrolled National Cancer Institute (NCI)

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2004-01
Primary completion: 2008-08
Completion: 2010-04

Outcome

Missed primary endpoint

Stopped: “The trial was discontinued early due to no confirmed partial responses.”

paper Single-agent bortezomib does not result in objective responses in biliary tract cancers. PMID 24512954 ↗

Publications

Results Denlinger CS, Meropol NJ, Li T, Lewis NL, Engstrom PF, Weiner LM, Cheng JD, Alpaugh RK, Cooper H, Wright JJ, Cohen SJ. A phase II trial of the proteasome inhibitor bortezomib in patients with advanced biliary tract cancers. Clin Colorectal Cancer. 2014 Jun;13(2):81-6. doi: 10.1016/j.clcc.2013.12.005. Epub 2014 Jan 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1.3 mg/m2	Intravenous