Phase II study of daily oral miltefosine (hexadecylphosphocholine) in advanced colorectal cancer

Eur J Cancer. 1993;29A(4):518-9. doi: 10.1016/s0959-8049(05)80142-x.

Abstract

34 patients with metastatic colorectal cancer were treated with the ether lipid miltefosine (hexadecylphosphocholine). Most patients received 3 x 50 mg daily, while in 11 patients the dose could be escalated to 4 x 50 mg daily. Nausea and vomiting were the most frequent side-effects occurring in all but 3 patients, nephrotoxicity was observed in 11 patients. Leucocytosis was observed in 24 and thrombocytosis in 17 patients. 28 patients are evaluable for response. 1 patient obtained a partial response of liver metastases for a duration of 8 months. 3 patients had stable disease while 24 progressed during treatment. We conclude that miltefosine in this dose and schedule has limited activity in colorectal cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Colorectal Neoplasms / drug therapy*
  • Female
  • Humans
  • Leukocytosis / chemically induced
  • Liver Neoplasms / secondary
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Phosphorylcholine / administration & dosage
  • Phosphorylcholine / adverse effects
  • Phosphorylcholine / analogs & derivatives*
  • Thrombocytosis / chemically induced
  • Vomiting / chemically induced

Substances

  • Antineoplastic Agents
  • Phosphorylcholine
  • miltefosine