A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma
- To verify that long-acting somatostatin analog octreotide (Sandostatin LAR) depot will
extend median survival from 5 months to 8.75 months in patients with locally advanced
or metastatic hepatocellular carcinoma with a CLIP score of 3 or more.
- To document tolerability of this drug in this patient population.
OUTLINE: Patients are stratified according to underlying degree of liver disease as defined
by CLIP score classification.
Patients receive short-acting octreotide subcutaneously three times daily on days 1-21 OR
days 1-28. If the patient tolerates short-acting octreotide, the first dose of long-acting
octreotide (Sandostatin LAR) depot will be given intramuscularly beginning on day 8 OR day
15. Treatment with long-acting octreotide repeats every 28 days in the absence of disease
progression or unacceptable toxicity.
After the completion of study treatment, patients are followed monthly for 6 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Bert H. O'Neil, MD
UNC Lineberger Comprehensive Cancer Center
United States: Institutional Review Board
|The University of North Carolina Lineberger Comprehensive Cancer Center||Chapel Hill, North Carolina 27599|