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Phase II Chemotherapy with Aclacinomycin in Previously Untreated Patients with Advanced Stage III/IV Soft Tissue Sarcomas

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedover 18SEG-SAR-81237

Objectives

I.  Determine the therapeutic effectiveness, response rate, and duration of 
response to aclacinomycin-A of previously untreated patients with advanced 
soft tissue sarcomas.
II.  Evaluate the incidence of cardiotoxicity and alopecia in these patients.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Previously untreated patients older 
than the age of 18 with histologically proven, nonresectable, measurable soft 
tissue sarcoma of the following histologies:  fibrosarcoma, malignant fibrous 
histiocytoma, malignant giant cell tumor of soft parts, liposarcoma, 
leiomyosarcoma, rhabdomyosarcoma (mixed, pleomorphic), angiosarcoma, malignant 
hemangiopericytoma, lymphangiosarcoma, synovial sarcoma, malignant schwannoma, 
alveolar soft-part sarcoma, malignant granular cell tumor, clear-cell sarcoma 
of tendon and aponeurosis, epithelioid sarcoma, spindle-cell sarcoma (not 
further classified), and undifferentiated sarcoma.  Patients with bone-only 
disease are ineligible.  The Karnofsky performance status must be at least 50 
percent and the estimated survival at least 60 days.  Bone marrow, kidney, and 
liver function must be adequate, and there may be no CNS metastases or a 
second primary cancer.  Patients must not have evidence of uncompensated heart 
failure or other serious cardiac dysfunction, or uncompensated hypertension.

Expected Enrollment

14-25 evaluable patients will be entered.  Protocol closed September 1983.

Outline

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

Published Results

Bertrand M, Multhauf P, Bartolucci A, et al.: Phase II study of aclarubicin in previously untreated patients with advanced soft tissue sarcoma: a Southeastern Cancer Study Group trial. Cancer Treat Rep 69(6): 725-726, 1985.

Trial Contact Information

Trial Lead Organizations

Southeastern Cancer Study Group

George A. Omura, MD, Protocol chair
Ph: 205-444-4617

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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