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	Closed	under 71		EORTC-16835A

Objectives

I.  Determine whether partial or complete responses can be achieved with 
1,2,4-triglycidylurazol in patients with non-small cell lung cancer.
II.  Assess the probability of an actual response rate (in cases of partial or 
complete response) in patients treated with 1,2,4-triglycidylurazol and 
determine whether further evaluation of therapeutic effectiveness is warranted.
III.  Further characterize the toxic effects of 1,2,4-triglycidylurazol in 
this group of patients.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 70 years of age or less with 
histologically confirmed squamous cell carcinoma, large cell carcinoma, or 
adenocarcinoma of the lung.  Lesions must be measurable or evaluable, and 
disease must be unresectable, recurrent, or metastatic.  Patients must not be 
candidates for curative surgery or radiotherapy.  A Zubrod performance status 
of 3 or better, a life expectancy of at least 3 months, and WBC and platelet 
counts of at least 4,000 and 100,000/cumm, respectively, are required.  There 
may be no radiotherapy or chemotherapy during the 4 weeks prior to entry (6 
weeks for nitrosoureas and mitomycin), and patients must have recovered from 
the toxic effects of prior therapy.  Brain involvement or leptomeningeal 
disease and prior radiotherapy to all present areas of measurable or evaluable 
disease exclude.  There may be no previous or concurrent other malignancy 
except for in-situ carcinoma of the uterine cervix and adequately treated 
basal or squamous cell skin carcinoma.  Patients who are poor medical risks 
because of nonmalignant systemic disease as well as those with active 
uncontrolled infection are ineligible.

Expected Enrollment

If there are 0, 1, 2, 3, or 4 or more responses among the first 14 patients 
treated, then 0, 1, 6, 9, or 11 additional patients will be entered, 
respectively.  This accrual scheme is carried out for patients with no prior 
chemotherapy and adenocarcinoma or squamous cell carcinoma (14 to 25 patients 
per category); all eligible patients with non-small cell lung cancer are 
entered until the appropriate number of adenocarcinoma and squamous cell 
carcinoma patients have been accrued.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  1,2,4-Triglycidylurazol, TGU.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Maurice J. Staquet, MD, Protocol chair		Ph: 32-2-541-3501