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 no age specified CAN-NCIC-IND10 NCI-T85-0101W, T85-0101, IND10

Objectives

I.  Determine the efficacy of tiazofurin given intravenously for 5 days in 
patients with metastatic breast cancer who have failed standard systemic 
therapy.
II.  Determine the toxicity of tiazofurin given on this schedule.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologic proof of 
breast cancer that is not curable by surgery or radiotherapy.  Disease must be 
metastatic and either unresponsive or no longer responsive to previous 
standard chemotherapeutic agents or hormone therapy.  There may have been no 
more than 2 prior combination chemotherapy regimens.  It is encouraged that 
tiazofurin be given as second-line chemotherapy when feasible.  There must be 
bidimensionally measurable disease by clinical or radiologic means (NB 
osteolytic metastases may be used as index lesions if sharply defined and at 
least one cm in diameter).  Patients with only osteoblastic disease and those 
with evaluable but not measurable disease are excluded, as are those with 
previously irradiated index lesions unless lesions have increased at least 50% 
in size since irradiation.  At least 3 weeks must have elapsed since prior 
radiotherapy or chemotherapy, and patients must have recovered from such 
therapy.  A life expectancy of at least 3 months, an ECOG performance status 
of 0-2, and adequate hematologic function are required.  A bilirubin of 35 
micromoles/liter or less, an SGOT of 45 U/liter or less, and normal serum 
creatinine, calcium, and uric acid are required.

Expected Enrollment

A minimum of 15 patients will be studied.  If there is evidence of response in 
the first 15 patients, 10 additional patients will be entered; if there is no 
response, the study will be closed.  3-5 patients will be accrued per month.

Outline

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

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

David Stewart, MD, FRCPC, Protocol chair(Contact information may not be current)		Ph: 613-737-7700 ext. 6802; 888-627-5346