Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed under physiologic 60 NCI MTS-84040 NCI-T84-0235D, T84-0235

Objectives

I.  Evaluate the safety and effectiveness of 4'-deoxydoxorubicin administered 
as a single agent on an intensive escalating dose schedule in patients with 
disseminated breast cancer.
II.  Evaluate possible chronic myocardial toxicity (using measurements of the 
cardiac ejection fraction and endomyocardial biopsy techniques) caused by 
4'-deoxydoxorubicin administered on this schedule.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients of a physiologic age of less 
than 60 years with histologic proof of breast cancer and clinical evidence of 
advanced (Stage IV) disease, provided they have measurable disease.  Patients 
must have had prior chemotherapy (no more than one prior course of 
chemotherapy, per October 1985 amendment); residual reversible toxic side 
effects of such therapy must have resolved.  Patients previously treated with 
anthracyclines must have no clinical signs of cardiotoxicity, a normal rest 
ejection fraction (55% or greater; 45% or greater, per October 1985 
amendment), and no greater than grade 2 myocardial damage as assessed by 
endomyocardial biopsy.  The rest left ventricular ejection fraction (LVEF) 
must be documented by cardiac radionuclide gated pool scan in all patients; 
those with a LVEF below 45% must have an endocardial biopsy; those with 
greater than grade 2 myocardial damage are ineligible.  An anticipated 
survival of at least 4 months, a performance status of 0-2, and normal renal, 
hepatic, and hematologic function are required.  Patients with a history of 
congestive heart failure, repeated tachyarrhythmias, or myocardial infarction 
over the previous 12 months are ineligible.

Expected Enrollment

It is expected that 30 evaluable patients will be accrued; if no responses are 
seen in the first 14 consecutive patients treated to toxicity, the trial will 
not be completed.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  4'-Deoxydoxorubicin, DxDx, NSC-267469.

Trial Contact Information

Trial Lead Organizations

Mount Sinai Medical Center

Paolo Paciucci, MD, Protocol chair		Ph: 212-772-3353 Email: paolo.paciucci@mssm.edu