Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach

NCT00061932 ↗

Phase 2 Completed 41 enrolled National Cancer Institute (NCI)

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial is studying how well bortezomib with or without irinotecan works in treating patients with gastroesophageal junction or stomach cancer that can not be removed by surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with irinotecan may kill more tumor cells.

Timeline

Start: 2003-04
Primary completion: 2009-12
Completion: 2013-11

Outcome

Missed primary endpoint

paper Objective response occurred in 3 of 29 patients (10 %, 95 % confidence intervals [CI] 2 %, 27 %) treated with bortezomib plus irinotecan PMID 24526575 ↗

paper We conclude that bortezomib is not effective for the treatment of advanced adenocarcinoma of the GEJ or stomach, whether used alone or in combination with irinotecan PMID 24526575 ↗

Publications

Results Ocean AJ, Christos P, Sparano JA, Shah MA, Yantiss RK, Cheng J, Lin J, Papetti M, Matulich D, Schnoll-Sussman F, Besanceney-Webler C, Xiang J, Ward M, Dilts KT, Keresztes R, Holloway S, Chen EX, Wright JJ, Lane ME. Phase II trial of bortezomib alone or in combination with irinotecan in patients with adenocarcinoma of the gastroesophageal junction or stomach. Invest New Drugs. 2014 Jun;32(3):542-8. doi: 10.1007/s10637-014-0070-0. Epub 2014 Feb 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1.3 mg/m2	Intravenous
Subject	Irinotecan	Small molecule	125 mg/m2	Intravenous