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 Closed 15 and over NCI MDA-DM-8420 NCI-T84-0369D, T84-0369

Objectives

I.  Determine the efficacy of tiazofurin administered by daily intravenous 
bolus (by rapid intravenous infusion per February 1985 revision) for 5 
consecutive days, repeated every 4 weeks, in patients with small cell 
bronchogenic carcinoma.
II.  Determine the qualitative and quantitative toxicity of tiazofurin 
administered on this schedule.
III.  Determine the duration of response and duration of survival in patients 
receiving this therapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 15 years of age or older 
with histologic proof of metastatic recurrent small cell bronchogenic 
carcinoma who are not candidates for known regimens or protocol treatments of 
higher efficacy or priority.  Patients must have measurable lesions (i.e., 
tumor abnormalities that can be objectively quantified by counting, palpation 
comparison, and/or ruler measurement) that can be evaluated for antitumor 
effect and bidimensionally measurable disease.  At least 4 weeks must have 
elapsed since prior chemotherapy, immunotherapy, or radiotherapy (except for 
localized radiotherapy to an area that does not compromise bone marrow), and 
patients must have recovered from the toxic effects of such therapy.  Patients 
should have failed no more than one prior regimen.  A life expectancy of at 
least 12 weeks, a Zubrod performance status of 2 or better, and adequate bone 
marrow, renal, and hepatic function are required.

Expected Enrollment

14 evaluable patients will be required initially.  If responses are seen, up 
to a total of 40 patients will be required.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Tiazofurin, NSC-286193.

Holoye PY, Carr DT, Dhingra HM, et al.: Phase II study of tiazofurin (NSC 286193) in the treatment of advanced small cell bronchogenic carcinoma. Invest New Drugs 6 (3): 217-8, 1988.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Paul Holoye, MD, Protocol chair(Contact information may not be current)		Ph: 713-792-6363; 800-392-1611