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

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.

• Authors: V K Malviya, P Y Liu, R O'Toole, D S Alberts, E Surwit, S Rosenoff, J H Ward, A Yu, J O'Sullivan, J B Craig
• Journal: American journal of clinical oncology (Am J Clin Oncol) Vol. 17 Issue 1 Pg. 37-40 (Feb 1994) ISSN: 0277-3732 [Print] United States
• PMID: 8311005 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, U.S. Gov't, P.H.S.)

Chemical References

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

Topics

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