Randomized, Dose-Finding Phase III Study of Lithium Gamolenate in Patients With Advanced Pancreatic Adenocarcinoma

Br J Surg. 2001 May;88(5):662-8. doi: 10.1046/j.0007-1323.2001.01770.x.

Abstract

Background: Chemotherapy for pancreatic cancer offers small survival benefits and considerable side-effects. Unsaturated fatty acids have an antitumour effect in experimental studies; in phase II studies few side-effects were seen.

Methods: In this group-sequential, open-label, randomized study, 278 patients with a diagnosis of inoperable pancreatic cancer were treated with either oral (700 mg daily for 15 days), low-dose (0.28 g/kg) or high-dose (0.84 g/kg) intravenous lithium gamolenate (LiGLA). The primary endpoint was survival time from randomization using Kaplan-Meier estimates.

Results: Median survival after oral and low-dose intravenous treatment was 129 and 121 days respectively. Median survival after high-dose intravenous treatment was 94 days. A good Karnofsky score and the absence of metastases were associated with increased survival. Haemolysis, a marker of rapid infusion, was associated with a median survival time of 249 days in the low-dose intravenous group.

Conclusion: Oral or low-dose intravenous LiGLA led to survival times similar to those of other treatments for pancreatic cancer although one subgroup (low-dose intravenous LiGLA with haemolysis) had longer survival. High-dose intravenous treatment appeared to have an adverse effect. Systemic treatment with LiGLA cannot be recommended for the treatment of pancreatic cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / administration & dosage*
  • Dose-Response Relationship, Drug
  • Fatty Acids, Unsaturated / administration & dosage
  • Humans
  • Infusions, Intravenous
  • Middle Aged
  • Pancreatic Neoplasms / drug therapy*
  • Survival Analysis
  • gamma-Globulins

Substances

  • Antineoplastic Agents
  • Fatty Acids, Unsaturated
  • gamma-Globulins
  • lithium gamolenate
  • pepsinated immunoglobulin G