A Phase II Evaluation of Clofazimine plus Doxorubicin in Advanced, Unresectable Primary Hepatocellular Carcinoma

• Published in: Oncology Vol. 57; no. 3; pp. 232 - 235
• Main Authors: Falkson, Carla I., Falkson, Geoffrey
• Format: Journal Article
• Language: English
• Published: Basel, Switzerland Karger 01.10.1999; S. Karger AG
• Subjects: Adolescent; Adult; Aged; Antibiotics, Antineoplastic - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Hepatocellular - drug therapy; Carcinoma, Hepatocellular - pathology; Clinical Study; Clofazimine - administration & dosage; Doxorubicin - administration & dosage; Female; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Liver Neoplasms - drug therapy; Liver Neoplasms - pathology; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; Medical sciences; Middle Aged; Survival Analysis; Treatment Outcome; Tumors; Hepatocellular carcinoma; Doxorubicin; Clofazimine; Antineoplastic agent; Human; Toxicity; Hepatic disease; Malignant tumor; Chemotherapy; Phase II trial; Unresectable; Digestive diseases; Anthracyclins; Survival curve
• ISSN: 0030-2414; 1423-0232
• DOI: 10.1159/000012036

The riminophenazine compound clofazimine has been shown to be a potent inhibitor of hepatocellular carcinoma (HCC) in vitro. Therapeutic benefit was claimed for patients with HCC treated with clofazimine in a recent clinical trial. The current trial was initiated to evaluate response and survival of patients with HCC receiving clofazimine plus doxorubicin. Twenty-eight patients were entered into the study, of whom 27 were evaluable for response and survival. No patients had a complete or partial response, and 9 had stable disease. The median survival time was 7 weeks. Toxicity was mild with yellow pigmentation of the skin resulting from the clofazimine, and leukopenia, nausea, vomiting and mucositis as expected from doxorubicin. Further studies using other riminophenazine compounds are warranted.