NCT00257426

Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	octreotide acetate	200mcg,3 times per day, 7 days per week, up to 36 weeks

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-02-01
• Completion: 2009-09-01
• First posted: 2005-11-22
• Last updated: 2012-02-14

Locations

1 site across 1 country: United States