|
||||||||||||||||||||||
|
|
Phase II Master Protocol for Evaluation of New Agents for Residual, Recurrent, or Metastatic Primary Liver Cancer --- Acivicin vs 4'-Deoxydoxorubicin
Basic Trial Information
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.Published Results 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] Related PublicationsChedid 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 Lead Organizations Eastern Cooperative Oncology Group
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. |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
A Service of the National Cancer Institute |