[Phase III clinical trial of elemenum emulsion in the management of malignant pleural and peritoneal effusions]

Zhonghua Zhong Liu Za Zhi. 1996 Nov;18(6):464-7.
[Article in Chinese]

Abstract

From July 1994 to June 1995, a prospective multicenter phase III clinical trial was conducted to evaluate the efficacy of Injectio Emulsioni Elemeni in the management of malignant effusions. Four hundred and eighty-four patients, including 313 with pleural effusion and 171 with peritoneal effusion, were evaluable. The drug was administered in 0.5% emulsion, with a dosage of 200 mg/m2 for intrapleural injection once every week for 1-2 weeks and 300-400 mg/m2 for intraperitoneal injection once or twice every week for 2 weeks. The response rates were 77.6% in patients with malignant pleural effusion, 66.1% in patients with peritoneal effusion. There were no bone marrow, liver, cardiac and renal toxicities; while fever, local pain and gastro-intestinal reaction were the major adverse effects. It is concluded that Elemenum emulsion is one of the active agents in the management of malignant effusions.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • English Abstract
  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antineoplastic Agents, Phytogenic / adverse effects
  • Antineoplastic Agents, Phytogenic / therapeutic use*
  • Ascitic Fluid / drug therapy*
  • Female
  • Fever / chemically induced
  • Humans
  • Injections, Intraperitoneal
  • Male
  • Middle Aged
  • Oils, Volatile / adverse effects
  • Oils, Volatile / therapeutic use*
  • Pleural Effusion, Malignant / drug therapy*
  • Prospective Studies
  • Sesquiterpenes*

Substances

  • Antineoplastic Agents, Phytogenic
  • Oils, Volatile
  • Sesquiterpenes
  • elemene