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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	no age specified	NCI	EST-2282

Objectives

I.  Identify new agents with cytotoxic activity in primary liver cancer for 
use later in Phase III trials.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologic proof of 
residual, recurrent, or metastatic primary liver (hepatocellular) carcinoma.  
There must be a measurable area of known malignant disease to serve as an 
objective indicator of response.  Patients must have a performance status of 
0-3 and adequate hematologic and renal function.  There must be no major 
surgery (resection or anastomosis) within the 3 weeks prior to entry or 
exploratory surgery and biopsy within the previous 2 weeks, no prior 
chemotherapy, and no radiotherapy within the month before entry; there may be 
no second malignancy other than basal or squamous cell carcinoma of the skin, 
no active infectious process, and no portal systemic encephalopathy.  Patients 
must have an adequate nutritional status (food intake of at least 1,500 
calories a day).  The prothrombin time must be adequate; patients with varices 
with recent hemorrhage or active heart disease are not eligible.  Patients to 
be treated with DHAD must have adequate cardiac status.

Expected Enrollment

30 evaluable patients per arm are required.  Accrual time is estimated at 
12-15 months for the initial 2 arms (Arms I and II).  Additional arms will 
require 6-7.5 additional months per arm to reach the same accession goal.  
Arms I and II closed December 1984.

Outline

Randomized study.  Arm III and IV activated October 1984.  Arms I and II 
closed December 1984.
Arm I:  Single-agent Chemotherapy.  Mitoxantrone, Dihydroxyanthracenedione, 
DHAD, NSC-301739.
Arm II:  Single-agent Chemotherapy.  cis-Platinum, CACP, NSC-119875.
Arm III:  Single-agent Chemotherapy.  Acivicin, AT-125, NSC-163501.
Arm IV:  Single-agent Chemotherapy.  4'-Deoxydoxorubicin, NSC-267469.

Falkson G, Cnaan A, Simson IW, et al.: A randomized phase II study of acivicin and 4'deoxydoxorubicin in patients with hepatocellular carcinoma in an Eastern Cooperative Oncology Group study. Am J Clin Oncol 13 (6): 510-5, 1990.[PUBMED Abstract]

Falkson G, Ryan LM, Johnson LA, et al.: A random phase II study of mitoxantrone and cisplatin in patients with hepatocellular carcinoma. An ECOG study. Cancer 60 (9): 2141-5, 1987.[PUBMED Abstract]

Chedid A, Ryan LM, Dayal Y, et al.: Morphology and other prognostic factors of hepatocellular carcinoma. Arch Pathol Lab Med 123 (6): 524-8, 1999.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

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