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 18 and over NCI SWOG-8866 SWOG-8866

Objectives

I.  Assess the response rate to piroxantrone administered as an intravenous 
bolus every 21 days in patients with Stage IV non-small cell lung cancer.
II.  Evaluate the qualitative and quantitative toxicities of this drug in this 
patient population.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age 
with Stage IV non-small cell lung cancer who are not eligible for Southwest 
Oncology Group protocols of higher priority; CNS metastases exclude.  Patients 
may have received radiotherapy and up to one prior biologic regimen; at least 
3 weeks must have elapsed since prior therapy, and patients must have 
recovered from the toxic effects of such therapy.  Measurable disease, defined 
as a bidimensionally measurable lesion with clearly defined margins by medical 
photograph, x-ray, or scan with at least 1 diameter greater than 0.5 cm or a 
palpable lesion with both diameters 2 cm or greater, is required; if the only 
site of measurable disease has been irradiated, unequivocal progression must 
be documented.  Bone lesions are not acceptable as measurable disease.  A SWOG 
performance status of 2 or better is required, as are the following laboratory 
values for organ function parameters:  granulocytes at least 1,500, platelets 
at least 100,000, and serum creatinine and serum bilirubin each no more than 
2.0 mg/dl.  A pretreatment serum albumin is also required.  There may be no 
history of heart disease including myocardial infarction, congestive heart 
failure, and significant ventricular arrhythmias; a radionuclide 
ventriculogram (MUGA scan) is required prior to entry and must indicate a 
normal resting cardiac ejection fraction (i.e., greater than 50%).  
Pretreatment bloodwork or other body fluid analyses necessary to determine 
eligibility and imaging studies used for tumor measurement must be obtained 
within 14 days prior to registration; other baseline screening exams and 
imaging studies must be carried out within 42 days prior to registration.  
There must have been no prior malignancy other than adequately treated basal 
cell skin cancer, in situ cervical cancer, or other cancer from which the 
patient has been disease-free for 5 years.  Fertile men and women must agree 
to use effective contraception; pregnant and lactating women are ineligible.

Expected Enrollment

If 1 or more responses are seen among the first 15 patients, an additional 15 
patients will be entered.  It is anticipated that 24 patients/year will be 
accrued.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Piroxantrone, NSC-349174.

Williamson SK, Crowley JJ, Livingston R, et al.: Phase II trial of piroxantrone in advanced non-small cell carcinoma of the lung. A Southwest Oncology Group study. Invest New Drugs 10 (1): 29-30, 1992.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Stephen Williamson, MD, Protocol chair		Ph: 913-588-6029 Email: swilliam@kumc.edu