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	Completed	no age specified	NCI	CLB-8341

Objectives

I.  Outline the procedure for Phase II studies to evaluate single or multiple 
agents for significant antitumor activity (in terms of frequency of complete 
or partial remission, duration of response, survival, quality of survival) in 
the treatment of inoperable, advanced or recurrent carcinoma of the breast.
II.  Evaluate acivicin for significant antitumor activity in the treatment of 
carcinoma of the breast.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed adenocarcinoma of the breast that is inoperable, recurrent, or 
metastatic.  Measurable disease (any mass reproducibly measurable in 2 
perpendicular diameters) is required.  Patients must have a performance score 
of 0-2 (less than 50% of waking hours in bed), a life expectancy of more than 
2 months, adequate nutrition, and adequate hematologic, renal, and hepatic 
function.  Two weeks must have passed since any major surgery, 4 weeks (2 
weeks if disease progression is documented and toxicity has cleared) since any 
chemotherapy (6 weeks for nitrosoureas, L-PAM, or mitomycin) or radiotherapy.  
Up to two prior chemotherapy regimens are allowed, and patients with visceral 
or rapid disease progression must have failed one standard chemotherapeutic 
regimen.  No previous or concomitant malignancy (other than curatively treated 
carcinoma in situ of the cervix or skin cancer) and no medical or psychiatric 
illness (other than metastatic disease to the brain or spinal cord) is allowed.

Expected Enrollment

A minimum of 20 patients will be treated; if there is at least one response, 
at least 40 patients will be entered.  Protocol suspended February 1984.  
Protocol closed June 1984.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Acivicin, AT-125, NSC-163501.

Booth BW, Korzun AH, Weiss RB, et al.: Phase II trial of acivicin in advanced breast carcinoma: a Cancer and Leukemia Group B study. Cancer Treat Rep 70(10): 1247-1248, 1986.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Emil Frei, MD, Protocol chair(Contact information may not be current)		Ph: 773-702-9171