An International Multicenter Randomized Controlled Trial of G17DT in Patients With Pancreatic Cancer : Pancreas

Secondary Logo

Journal Logo

Original Articles

An International Multicenter Randomized Controlled Trial of G17DT in Patients With Pancreatic Cancer

Gilliam, Andrew D. FRCS*; Broome, Paul MD; Topuzov, Eskender G. D Med Sci; Garin, Avgust M. D Med Sci§; Pulay, Istvan MD; Humphreys, Jane BSc; Whitehead, Anne DSc#; Takhar, Arjun FRCS**; Rowlands, Brian J. FRCS**; Beckingham, Ian J. FRCS**

Author Information
Pancreas 41(3):p 374-379, April 2012. | DOI: 10.1097/MPA.0b013e31822ade7e

Abstract

Objectives 

This study aimed to investigate G17DT, an immunogen producing neutralizing antibodies against the tumor growth factors amidated and glycine-extended forms of gastrin-17, in the treatment of pancreatic cancer.

Methods 

A randomized, double-blind, placebo-controlled, group-sequential multicenter trial of G17DT in patients with advanced pancreatic cancer unsuitable for or unwilling to take chemotherapy. Inclusion criteria were a Karnofsky performance score of 60 or higher and a life expectancy of more than 2 months. Patients received G17DT or placebo emulsion at weeks 0, 1, 3, 24, and 52. The primary end point was survival, and secondary end points were tolerability, Karnofsky performance.

Results 

A total of 154 patients were recruited: 79 G17DT and 75 placebo. A final analysis of the intention-to-treat population, using a proportional hazards model, stratifying by disease stage and adjusting for interim analysis, gave a hazard ratio for mortality of 0.75 (95% confidence interval, 0.51–1.10, P = 0.138; G17DT/placebo). A conventional analysis without adjustment for disease stage or interim analysis, censoring for chemotherapy and excluding protocol violators, gave median survival periods of 151 (G17DT) and 82 days (placebo) (log-rank test, P = 0.03).

Patients developing anti-G17DT responses (73.8%) survived longer than nonresponders or those on placebo (median survival, 176 vs 63 vs 83; log-rank test, P = 0.003). G17DT was well tolerated.

Abbreviations 

HR - hazard ratio, ITT - intention to treat, CI - confidence interval

Copyright © 2012 Wolters Kluwer Health, Inc. All rights reserved.

You can read the full text of this article if you:

Access through Ovid