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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	MSKCC-8739 NCI-T87-0098C, T87-0098

Objectives

I.  Evaluate the antitumor activity of amonafide in patients with Stage III or 
IV non-small cell lung cancer who have not received prior chemotherapy.
II.  Characterize more fully the toxicity of amonafide in this patient 
population when treated daily for 5 days every 3 weeks.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age who 
have histologically confirmed Stage III or IV non-small cell lung cancer that 
is not curable by surgery or radiotherapy.  Prior chemotherapy excludes; only 
one prior therapy with a biological regimen not including IL-2 and LAK cells 
is permitted.  Patients must have measurable or evaluable indicator lesions 
that have not been irradiated; there may have been no radiotherapy to major 
bone marrow-containing areas for 3 weeks prior to start of therapy.  Pleural 
effusions, bone metastases, brain metastases, elevated enzyme levels, and 
lesions on radionuclide scans are not acceptable as sole indicator lesions.  A 
Karnofsky performance status of 50% or better, WBC of at least 4,000, platelet 
count of at least 150,000, bilirubin no greater than 1.5 mg%, and serum 
creatinine of no more than 1.5 mg% or a creatinine clearance of at least 50 
cc/minute are required.  Patients must have a stable heart rhythm, no active 
angina, and no clinical evidence of congestive heart failure; prior malignancy 
(except basal cell skin cancer) excludes.

Expected Enrollment

14 patients will be studied initially; if any responses are seen, 11 
additional patients will be entered for a total of 25 patients.

Outline

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

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Mark Kris, MD, Protocol chair		Ph: 212-639-7590; 800-525-2225