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

V. K. Malviya, P. Y. Liu, R. O'Toole, David S Alberts, E. Surwit, S. Rosenoff, J. H. Ward, A. Yu, J. O'Sullivan, J. B. Craig

Research output: Contribution to journalArticle

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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/ml, 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.

Original languageEnglish (US)
Pages (from-to)37-40
Number of pages4
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume17
Issue number1
StatePublished - 1994
Externally publishedYes

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amonafide
Adenocarcinoma
Endometrial Neoplasms
Phlebitis
Agranulocytosis

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase II trial of amonafide in patients with advanced metastatic or recurrent endometrial adenocarcinoma : A Southwest Oncology Group study. / Malviya, V. K.; Liu, P. Y.; O'Toole, R.; Alberts, David S; Surwit, E.; Rosenoff, S.; Ward, J. H.; Yu, A.; O'Sullivan, J.; Craig, J. B.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 17, No. 1, 1994, p. 37-40.

Research output: Contribution to journalArticle

Malviya, V. K. ; Liu, P. Y. ; O'Toole, R. ; Alberts, David S ; Surwit, E. ; Rosenoff, S. ; Ward, J. H. ; Yu, A. ; O'Sullivan, J. ; Craig, J. B. / Phase II trial of amonafide in patients with advanced metastatic or recurrent endometrial adenocarcinoma : A Southwest Oncology Group study. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 1994 ; Vol. 17, No. 1. pp. 37-40.
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AU - Alberts, David S

AU - Surwit, E.

AU - Rosenoff, S.

AU - Ward, J. H.

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AU - Craig, J. B.

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