AG0001H

AG001H Phase II pilot study of Sandostatin LAR ® in the treatment of advanced hepatocellular  carcinoma.

Share

Trial Status

Completed

Cancer Type

Liver Cancer

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.

Trial Status

Completed

Cancer Type

Liver Cancer

Publication Reference

  1. 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.
  2. 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.
  3. Nowak A, Chow P, Findlay M. Systemic therapy for advanced hepatocellular carcinoma: a review. European Journal of Cancer 2004; 40(10): 1474-1484.
  4. Nowak A, Findlay M, Culjak G, Stockler M. Tamoxifen for hepatocellular carcinoma. Cochrane Database of Systematic Reviews 2004; (3): CD001024

Conference Presentation Reference

  1. 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.
  2. 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