Phase II study of amonafide in the treatment of patients with advanced squamous cell carcinoma of the head and the neck - An Illinois Cancer Center Study

Fred Rosen, Everett E. Vokes, Thomas Lad, Merrill Kies, James Wade, Lary J. Kilton, Richard Blough, Suzanne French, Michael Mullane, Al B. Benson*

*Corresponding author for this work

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Amonafide (nafidimide), a synthetic organic compound with an inhibitory effect on cellular replication, was used in a phase II study conducted by the Illinois Cancer Center in order to assess its efficacy and toxicity in advanced or recurrent squamous cell cancer of the head and neck. Eligible patients had received no more than one prior adjuvant or neoadjuvant chemotherapy, had normal bone marrow, renal and hepatic function, ECOG performance status of 0-2, and bidimensionally measurable disease. Eligible patients were administered amonafide at a starting dose of 300 mg/m2 for five consecutive days every 3 weeks with dose escalation or de-escalation according to established hematologic criteria in the absence of disease progression. Nineteen of 22 entered patients were evaluable for response and all patients were evaluable for toxicity. Eleven of 19 patients achieved stable disease. Median time to progression after start of treatment was 57 days, for the 18 patients for whom the date of progression is known. There were no partial or complete responses. Hematologic toxicity was dose limiting with grade 3-4 neutropenia in 50 percent of patients and 4 deaths associated with neutropenic sepsis. Non-hematologic toxicity was mild to moderate with nausea and vomiting predominating. In this study, amonafide was a myelotoxic, inactive treatment in advanced/ recurrent head and neck cancer. Further use in head and neck cancer appears unwarranted.

Original languageEnglish (US)
Pages (from-to)249-252
Number of pages4
JournalInvestigational New Drugs
Volume13
Issue number3
DOIs
StatePublished - Sep 1 1995

Fingerprint

amonafide
Head and Neck Neoplasms
Neoplasms
Therapeutics
Squamous Cell Neoplasms
Carcinoma, squamous cell of head and neck
Neutropenia
Nausea
Vomiting
Disease Progression
Sepsis
Bone Marrow

Keywords

  • amonafide (nafidimide)
  • head and neck carcinoma
  • phase II trial
  • squamous cell carcinoma

ASJC Scopus subject areas

  • Pharmacology
  • Molecular Medicine

Cite this

Rosen, Fred ; Vokes, Everett E. ; Lad, Thomas ; Kies, Merrill ; Wade, James ; Kilton, Lary J. ; Blough, Richard ; French, Suzanne ; Mullane, Michael ; Benson, Al B. / Phase II study of amonafide in the treatment of patients with advanced squamous cell carcinoma of the head and the neck - An Illinois Cancer Center Study. In: Investigational New Drugs. 1995 ; Vol. 13, No. 3. pp. 249-252.
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Phase II study of amonafide in the treatment of patients with advanced squamous cell carcinoma of the head and the neck - An Illinois Cancer Center Study. / Rosen, Fred; Vokes, Everett E.; Lad, Thomas; Kies, Merrill; Wade, James; Kilton, Lary J.; Blough, Richard; French, Suzanne; Mullane, Michael; Benson, Al B.

In: Investigational New Drugs, Vol. 13, No. 3, 01.09.1995, p. 249-252.

Research output: Contribution to journalArticle

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T1 - Phase II study of amonafide in the treatment of patients with advanced squamous cell carcinoma of the head and the neck - An Illinois Cancer Center Study

AU - Rosen, Fred

AU - Vokes, Everett E.

AU - Lad, Thomas

AU - Kies, Merrill

AU - Wade, James

AU - Kilton, Lary J.

AU - Blough, Richard

AU - French, Suzanne

AU - Mullane, Michael

AU - Benson, Al B.

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N2 - Amonafide (nafidimide), a synthetic organic compound with an inhibitory effect on cellular replication, was used in a phase II study conducted by the Illinois Cancer Center in order to assess its efficacy and toxicity in advanced or recurrent squamous cell cancer of the head and neck. Eligible patients had received no more than one prior adjuvant or neoadjuvant chemotherapy, had normal bone marrow, renal and hepatic function, ECOG performance status of 0-2, and bidimensionally measurable disease. Eligible patients were administered amonafide at a starting dose of 300 mg/m2 for five consecutive days every 3 weeks with dose escalation or de-escalation according to established hematologic criteria in the absence of disease progression. Nineteen of 22 entered patients were evaluable for response and all patients were evaluable for toxicity. Eleven of 19 patients achieved stable disease. Median time to progression after start of treatment was 57 days, for the 18 patients for whom the date of progression is known. There were no partial or complete responses. Hematologic toxicity was dose limiting with grade 3-4 neutropenia in 50 percent of patients and 4 deaths associated with neutropenic sepsis. Non-hematologic toxicity was mild to moderate with nausea and vomiting predominating. In this study, amonafide was a myelotoxic, inactive treatment in advanced/ recurrent head and neck cancer. Further use in head and neck cancer appears unwarranted.

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