Phase II study of amonafide (nafidamide, NSC 308847) in advanced colorectal cancer

Invest New Drugs. 1991 Feb;9(1):65-7. doi: 10.1007/BF00194547.

Abstract

Amonafide, a benzisoquinoline-1,3-dione with anti-tumor activity in preclinical screens, was administered to patients with recurrent or metastatic bidimensionally measurable colorectal cancer. Fourteen patients with no prior chemotherapy for advanced disease, performance status 0-1, and normal bone marrow, renal, and hepatic function were entered. Amonafide 300 mg/m2 was administered intravenously over 1 hour daily for five consecutive days; courses were repeated every three weeks. The major side effect was neutropenia: Grade 3 or 4 toxicity occurred in 5/14 patients. Other toxicities included nausea and vomiting, flulike symptoms, fever, rash and alopecia. Three patients had stable disease, but there were no responses observed. Amonafide at this dose and schedule has no activity in the treatment of colorectal cancer.

Publication types

  • Clinical Trial

MeSH terms

  • Adenine
  • Adenocarcinoma / drug therapy*
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Colorectal Neoplasms / drug therapy*
  • Drug Evaluation
  • Humans
  • Imides*
  • Isoquinolines / adverse effects
  • Isoquinolines / therapeutic use*
  • Middle Aged
  • Naphthalimides
  • Organophosphonates

Substances

  • Antineoplastic Agents
  • Imides
  • Isoquinolines
  • Naphthalimides
  • Organophosphonates
  • amonafide
  • Adenine