Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer
- Conditions
- Liver Cancer
- Registration Number
- NCT00257426
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Median survival 6 months
- Secondary Outcome Measures
Name Time Method number of subjects with toxicities 6 months Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0
Trial Locations
- Locations (1)
The University of North Carolina Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States