A dose-finding study of miltefosine (hexadecylphosphocholine) in patients with metastatic solid tumours

J Cancer Res Clin Oncol. 1992;118(8):606-8. doi: 10.1007/BF01211805.

Abstract

The ether lipid miltefosine (hexadecylphosphocholine) was orally given to patients with various tumours in a dose-finding study. All patients initially received a daily total dose of 100 mg, which in the absence of side-effects was increased to 150 mg and further to 200 mg. A total of 54 patients were entered and were evaluable for gastrointestinal toxicity. Nausea and vomiting were found to be dose-limiting; 22% of patients ultimately tolerated a dose of 100 mg, 59% tolerated a dose of 150 mg and 19% tolerated a dose of 200 mg. In addition 30% of patients developed renal dysfunction, which was thought to be related to the drug. No other toxicities were observed. For further phase II studies it is recommended that one starts with a dose of 150 mg daily, divided over three administrations.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Carcinoma, Non-Small-Cell Lung / drug therapy
  • Carcinoma, Non-Small-Cell Lung / secondary
  • Carcinoma, Squamous Cell / drug therapy
  • Carcinoma, Squamous Cell / secondary
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / secondary
  • Dose-Response Relationship, Drug
  • Female
  • Head and Neck Neoplasms / drug therapy*
  • Head and Neck Neoplasms / secondary
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / secondary
  • Male
  • Middle Aged
  • Phosphorylcholine / administration & dosage
  • Phosphorylcholine / analogs & derivatives*

Substances

  • Antineoplastic Agents
  • Phosphorylcholine
  • miltefosine