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	EST-2182

Objectives

I.  Assess the therapeutic capability of new agents to cause tumor shrinkage, 
prolong the time to treatment failure, and prolong survival in breast cancer 
patients who are resistant to conventional drug therapy.
II.  Assess the toxicity of each new agent.
III.  Assess the therapeutic efficacy and toxicity of acivicin.
IV.  Assess the therapeutic efficacy and toxicity of aminothiadiazole.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
documented, measurable or evaluable (by ECOG criteria), metastatic breast 
adenocarcinoma who have been exposed to at least one (but not more than 2) 
chemotherapeutic regimen for metastatic disease.  Patients must have a 
performance status of 0-2 and adequate hematologic, renal, and hepatic 
function.  As per Addendum 5, January 1985, patients with abnormal hepatic 
function who satisfy all other entry requirements are eligible to receive 
aminothiadiazole.  At least 3 weeks must have elapsed since prior surgical 
hormonomanipulation, and disease progression must have been documented since 
surgery; at least 3 weeks must have elapsed since prior chemotherapy (5 weeks 
for mitomycin-C, dibromodulcitol, or nitrosoureas) or there must be laboratory 
evidence of adequate recovery from effects of therapy.  Prior medical 
hormonomanipulation is allowed, provided that progressive disease was 
demonstrated within 12 weeks of the initiation of therapy or that therapy was 
discontinued following relapse from a response.  Patients with concurrent or 
recent wide field radiotherapy encompassing more than 5% of the marrow, 
debilitating medical or psychiatric illness, or history of other malignant 
neoplasms are not eligible.  Pregnant patients are not eligible.  Per Addendum 
1, April 1983, patients who have had prior treatment with the study drug and 
those with creatinine clearance less than 10 mg percent are excluded.  
Patients with brain metastases or known allergy to allopurinol are ineligible 
for the aminothiadiazole study.

Expected Enrollment

Up to 30 evaluable patients will be entered on each treatment.  As of Addendum 
3, October 1983, the acivicin treatment arm is closed to patient entry and the 
protocol suspended pending activation of a new treatment arm.  As of July 
1984, the protocol is active with the aminothiadiazole treatment arm open to 
patient entry.  Protocol closed March 1985.

Outline

Nonrandomized study.  Within the framework of this Master Protocol, new 
chemotherapeutic agents will be sequentially evaluated.
Single-agent Chemotherapy.  Acivicin, AT-125, NSC-163501.  Closed to patient 
accrual October 1983.
Single-agent Chemotherapy.  Aminothiadiazole, A-TDA, NSC-4728.  Open to 
patient accrual July 1984.

Willson JK, Knuiman MW, Skeel RT, et al.: Phase II clinical trial of acivicin in advanced breast cancer: an Eastern Cooperative Oncology Group study. Cancer Treat Rep 70(10): 1237-1238, 1986.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Alex Chang, MD, Protocol chair		Ph: 65-6880-2222 Email: alexchang@imc.jhmi.edu