Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer
RATIONALE: Octreotide may stop or slow the growth of tumor cells and may be an effective treatment for liver cancer.
PURPOSE: This phase II trial is studying how well octreotide works in treating patients with locally advanced or metastatic liver cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma|
- Median survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- number of subjects with toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0
|Study Start Date:||July 2005|
|Study Completion Date:||September 2009|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
Drug: octreotide acetate
- 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.
|United States, North Carolina|
|The University of North Carolina Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Bert H. O'Neil, MD||UNC Lineberger Comprehensive Cancer Center|