Phase II trial of amonafide in patients with advanced metastatic or recurrent endometrial adenocarcinoma. A Southwest Oncology Group study

Am J Clin Oncol. 1994 Feb;17(1):37-40. doi: 10.1097/00000421-199402000-00008.

Abstract

Amonafide, a benzisoquinoline-1,3-dione was administered to 38 patients with recurrent or metastatic, bidimensionally measurable endometrial cancer. There were 34 patients with no prior cytotoxic chemotherapy, performance status of 0-2, and normal bone marrow, renal, and hepatic function were eligible for response and toxicity evaluation. Amonafide, 300 mg/m2, was administered intravenously over 1 hour daily for 5 consecutive days. Courses were repeated every 21 days. The major grade 3 or 4 toxicities were hematologic with granulocytopenia in 18 patients (53%), thrombocytopenia in 6 patients (18%), and anemia in 8 patients (24%). Infectious complications occurred in 3 patients (9%). Other side effects included cardiac dysrhythmias, hypotension, pain and phlebitis at the site of injection, nausea, vomiting, and flu-like symptoms. The overall objective response rate was 6% (95% confidence interval of 1-20%); 2 patients had a complete response (6%), 9 patients had stable disease (26%) and 21 patients had progressive disease (62%). Two patients had insufficient follow-up for response determination and are assumed to be nonresponders. The median survival of the eligible patients was 8 months. With the toxicity observed and the low response rate, amonafide at this dose and schedule has no efficacy in the treatment of endometrial cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adenine
  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / secondary
  • Adult
  • Aged
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Endometrial Neoplasms / drug therapy*
  • Endometrial Neoplasms / pathology
  • Female
  • Humans
  • Imides / adverse effects
  • Imides / therapeutic use*
  • Intercalating Agents / adverse effects
  • Intercalating Agents / therapeutic use*
  • Isoquinolines / adverse effects
  • Isoquinolines / therapeutic use*
  • Middle Aged
  • Naphthalimides
  • Neoplasm Recurrence, Local / drug therapy
  • Organophosphonates
  • Survival Analysis
  • Treatment Outcome

Substances

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