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.
OBJECTIVES: Primary * 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. Secondary * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
200mcg,3 times per day, 7 days per week, up to 36 weeks
The University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Median survival
Time frame: 6 months
number of subjects with toxicities
Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0
Time frame: 6 months
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