- AG0001H
Trial Status
Completed
Cancer Type
Liver Cancer
Protocol Title
Phase II pilot study of Sandostatin LAR ® in the treatment of advanced hepatocellular carcinoma.
Purpose of the Study
Hepatocellular Carcinoma (HCC) is one of the most common tumours world-wide. It is a significant cause of death in Eastern Asia and sub-saharan Africa, although less “common in western populations, the incidence is increasing due to the prevalence of Hepatitis C infections. A recently published study suggested that octreotide could improve survival in advanced disease. However, the biological basis of this finding is unclear and the data require urgent confirmation before proceeding to a larger multinational phase III trial.
- Is the delivery of Sandostatiu LAR® to this population is feasible?
- Is the delivery of Sandostatiu LAR® is safe?
- Is Sandostatin LAR ® is more active in patients with measurable somatostatin receptors than those who do not express these receptors?
PRINCIPAL INVESTIGATOR
A/Prof Jonathan Cebon
Prof Michael Findlay
Funding
Novartis Pharmaceuticals Australia Pty Limited
DETAILED INFORMATION AVAILABLE
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here
Trial Status
Completed
Cancer Type
Liver Cancer
Publication Reference
- Nowak AK, Cebon J, Hargreaves C, Dhillon H, Findlay M, Gebski V, Stockler MR. Assessment of health-related quality of life and patient benefit as outcome measures for clinical trials in hepatocellular carcinoma. Asia-Pacific Journal of Clinical Oncology 2008; 4: 55-67.
- Cebon J, Hargreaves C, Stockler M, Nowak A, Dhillon H, Dickman B, Gebski V; Australasian Gastro-Intestinal Trials Group (AGITG) AG0001H Investigators. Somatostatin receptor expression, tumour response, and quality of life in patients with advanced hepatocellular carcinoma treated with long-acting octreotide. British Journal of Cancer 2006; 95(7): 853–861.
- Nowak A, Chow P, Findlay M. Systemic therapy for advanced hepatocellular carcinoma: a review. European Journal of Cancer 2004; 40(10): 1474-1484.
- Nowak A, Findlay M, Culjak G, Stockler M. Tamoxifen for hepatocellular carcinoma. Cochrane Database of Systematic Reviews 2004; (3): CD001024
Conference Presentation Reference
- Cebon J, Findlay M, Hargreaves C, Stockler M, Thompson P, Boyer M, Roberts S, Poon A, Dickman B, Gebski V. Somatostatin receptor expression and clinical effects of octreotide in patients with advanced hepatocellular carcinoma. Clinical Oncological Society of Australia 30th Annual Scientific Meeting; 25–28 Nov 2003; Perth.
- Cebon J, Findlay M, Hargreaves C, Stockler M, Thompson P, Boyer M, Roberts S, Poon A, Dickman B, Gebski V. Somatostatin receptor expression and clinical effects of Sandostatin LAR in patients with advanced hepatocellular carcinoma. American Society of Clinical Oncology; 31 May–3 June 2003; Chicago.
Aims/Hypothesis
- Is the delivery of Sandostatiu LAR® to this population is feasible?
- Is the delivery of Sandostatiu LAR® is safe?
- Is Sandostatin LAR ® is more active in patients with measurable somatostatin receptors than those who do not express these receptors?
Summary
Hepatocellular Carcinoma (HCC) is one of the most common tumours world-wide. It is a significant cause of death in Eastern Asia and sub-saharan Africa, although less “common in western populations, the incidence is increasing due to the prevalence of Hepatitis C infections. A recently published study suggested that octreotide could improve survival in advanced disease. However, the biological basis of this finding is unclear and the data require urgent confirmation before proceeding to a larger multinational phase III trial.
Principal Investigator
Associate Professor Jonathan Cebon, Medical Oncologist, Austin Health VIC
Professor Michael Findlay, Medical Oncologist, Auckland Hospital NZ
Funding
Novartis Pharmaceuticals Australia Pty Limited