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 NCI-D81-039-464

Objectives

I.  Evaluate the therapeutic efficacy of aclacinomycin as a single agent in 
the treatment of advanced, measurable ovarian carcinoma.
II.  Evaluate the cardiotoxicity of aclacinomycin.
III.  Evaluate any cross resistance with adriamycin.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously treated patients with 
histologically confirmed advanced, recurrent, persistent, metastatic ovarian 
epithelial carcinoma with documented disease progression.  Patients must have 
measurable disease and may not be eligible for a higher-priority protocol.  
The performance status must be 0-3; renal, hepatic, hematopoietic, and 
nutritional status must be adequate.  At least 3 weeks must have elapsed since 
major surgery, 2 weeks since exploration and biopsy only, and 4 weeks since 
previous chemotherapy or radiotherapy; there may have been no irradiation of 
the indicator lesions.  There may be no active heart disease or active 
infectious process.

Expected Enrollment

An accrual of 25-30 patients is anticipated.  Protocol closed.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Aclacinomycin, ACM, NSC-208734.

Trial Contact Information

Trial Lead Organizations

Abramson Cancer Center of the University of Pennsylvania

Daniel Haller, MD, Protocol chair		Ph: 215-662-6318