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	75 and under		EORTC-16835B

Objectives

I.  Determine whether partial or complete responses can be achieved with 
1,2,4-triglycidylurazol in patients with advanced colorectal carcinoma.
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 75 years of age or less with 
a histologic diagnosis of recurrent or metastatic colorectal adenocarcinoma 
that is not amenable to curative surgery.  Patients must have measurable or 
evaluable lesions with documented progression during the 2 months prior to 
entry.  A performance status of 0-2 (WHO criteria), a life expectancy of 
greater than 3 months, and adequate renal, hepatic, and hematologic function 
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 all toxic effects of prior therapy.  Brain involvement and 
prior radiotherapy to indicator lesions 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.

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