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Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

2014-07-24 14:26:18 | BioPortfolio

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.

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Liver Cancer

Intervention

octreotide acetate

Location

The University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill
North Carolina
United States
27599

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:26:18-0400

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Medical and Biotech [MESH] Definitions

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