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-55845

Objectives

I.  Investigate the antitumor activity of 1,2,4-triglycidylurazol administered 
on an intermittent single-dose schedule in patients with advanced epithelial 
cancer of the ovary.
II.  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 aged no more than 70 years 
with histologically verified ovarian carcinoma originating from the epithelial 
surface of the ovary (according to WHO classification), including serous, 
mucinous, endometrioid, clear cell, and undifferentiated adenocarcinomas; 
Brenner tumor and tumors of border-line malignancy are excluded.  Patients 
should have measurable or evaluable disease outside previously irradiated 
areas with documented disease progression.  Prior chemotherapy with 
nitrosoureas or mitomycin-C is not permitted; at least 4 weeks must have 
elapsed since prior radiotherapy, hormone therapy, or other chemotherapy, and 
all toxic manifestations of prior treatments must have resolved.  A WHO 
performance status of 2 or better and a life expectancy of at least 3 months 
are required.  At the start of treatment, patients must demonstrate a WBC at 
least 4,000/cumm, platelets at least 100,000/cumm, bilirubin no more than 1.5 
mg/dl (or 26 micromol/l), and creatinine no higher than 1.5 mg/dl (or 132 
micromol/l) and/or creatinine clearance at least 60 ml/min/1.73 sqm BSA.  
Patients with brain involvement or leptomeningeal disease, previous or 
concurrent cancer at other sites (except cone-biopsied in-situ carcinoma of 
the uterine cervix and adequately treated basal or squamous cell carcinoma of 
the skin), active uncontrolled infection, or other systemic disease that would 
render patient a poor medical risk are excluded.

Expected Enrollment

Initially 14 patients will be treated; if 1, 2, 3, or 4 or 5 responses are 
observed, than 1, 6, 9, or 11 additional patients, respectively, will be 
entered.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  1,2,4-Triglycidylurazol, TGU, NSC-332488.

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