Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	16 and over	NCI	ICC-88N2 NCI-T88-0067D, T88-0067

Objectives

I.  Assess the usefulness of amonafide in the treatment of squamous cell 
carcinoma of the head and neck.
II.  Add to the accumulated knowledge of the toxicity of amonafide.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 16 years of age 
with histologically confirmed squamous cell carcinoma of the head and neck 
that is either 1) recurrent or metastatic or 2) locally advanced, and is 
judged incurable by surgery or radiotherapy.  Patients may have received no 
more than one prior adjuvant/neoadjuvant chemotherapy regimen, with no 
evidence of progressive or recurrent disease during the course of that 
treatment; no more than one prior immunotherapy regimen is allowed.  At least 
28 days must have elapsed since any prior chemotherapy, immunotherapy, or 
radiotherapy.  Bidimensionally measurable disease must be present, with at 
least one lesion designated as an indicator lesion; a lesion pictured by 
ultrasound or computerized axial tomography is measurable if at least two 
perpendicular diameters can be measured and the procedure can be repeated 
serially.  Malignant hepatomegaly is acceptable as an indicator lesion only 
when the liver contains biopsy-proven cancer and extends at least 5 cm below 
the costal margin.  An ECOG performance status of 2 or better and a life 
expectancy of at least 60 days are required.  Patients must meet the following 
hematologic, renal, and hepatic criteria (measured within 14 days prior to 
entry):  WBC at least 4,000, platelets at least 100,000, granulocytes at least 
2,000, and hemoglobin at least 10 g/dl (transfusion is allowed); creatinine no 
greater than 1.7 mg/dl; and bilirubin no greater than 1.7 and SGPT or SGOT 
each no greater than 2.0 times the upper limit of normal.  If bilirubin, SGPT, 
or SGOT exceeds the upper limit of normal, the liver must be evaluated 
radiographically (e.g., by CT scan) prior to therapy.  Aside from skin cancer, 
there may have been no other malignancy within the past 5 years; weight loss 
exceeding 15% of body weight within the past 2 months is not allowed.  Current 
acute or chronic infection or brain metastases exclude.  Patients must not be 
pregnant and must be physically incapable of becoming pregnant or be currently 
using adequate contraception, with a firm commitment to continue.

Expected Enrollment

Up to 25 patients may be accrued in order to obtain 15 evaluable patients; if 
at least one objective response is seen in the first 15 evaluable patients, 
accrual will continue until 15 additional evaluable patients are entered, to a 
maximum of 40 patients total.  An estimated 18 to 24 months will be required 
for accrual.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Amonafide, NSC-308847.

Rosen F, Kies M, Wade J, et al.: Phase II study of amonafide in the treatment of patients with advanced squamous cell carcinoma of the head and neck: an Illinois Cancer Center trial. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-914, 283, 1993.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Everett Vokes, MD, Protocol chair(Contact information may not be current)		Ph: 312-908-5250