An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer

Pancreas. 2012 Apr;41(3):374-9. doi: 10.1097/MPA.0b013e31822ade7e.


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Cancer Vaccines / adverse effects
  • Cancer Vaccines / therapeutic use*
  • Double-Blind Method
  • Europe
  • Female
  • Gastrins / adverse effects
  • Gastrins / immunology*
  • Gastrins / therapeutic use*
  • Humans
  • Kaplan-Meier Estimate
  • Karnofsky Performance Status
  • Life Expectancy
  • Male
  • Middle Aged
  • Pancreatic Neoplasms / immunology
  • Pancreatic Neoplasms / mortality
  • Pancreatic Neoplasms / pathology
  • Pancreatic Neoplasms / therapy*
  • Placebos
  • Proportional Hazards Models
  • Prospective Studies
  • Time Factors
  • Treatment Outcome


  • Cancer Vaccines
  • Gastrins
  • Placebos
  • gastrin immunogen
  • gastrin 17