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Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00257426
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : February 14, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: octreotide acetate Phase 2

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma
Study Start Date : July 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : September 2009

Intervention Details:
  • Drug: octreotide acetate
    200mcg,3 times per day, 7 days per week, up to 36 weeks
    Other Name: Sandostatin

Primary Outcome Measures :
  1. Median survival [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. number of subjects with toxicities [ Time Frame: 6 months ]
    Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Newly diagnosed or recurrent hepatocellular carcinoma (HCC) as defined by tissue biopsy OR alpha fetoprotein (AFP) > 1,000 ng/mL with compatible mass on CT scan or MRI

    • Recurrence of previously resected HCC will not require tissue confirmation if there is clear radiographic recurrence, in the judgment of the investigator
  • Locally advanced OR metastatic disease
  • Unmeasurable disease allowed if initial diagnosis was made according to the above criteria and/or recurrence has been confirmed by tissue biopsy or radiological imaging
  • CLIP score ≥ 3
  • Not a candidate for surgical resection or liver transplant
  • Not a candidate for loco-regional therapy (e.g., ablation, embolization, hepatic arterial infusion therapy), but could have received such therapy in the past
  • No fibrolamellar HCC
  • No clinically apparent central nervous system metastases or carcinomatous meningitis


  • Life expectancy ≥ 8 weeks
  • Karnofsky performance status 60-100%
  • Hemoglobin ≥ 8.5 g/dL
  • Platelet count ≥ 50,000/mm³
  • Total bilirubin ≤ 5.0 mg/dL
  • AST or ALT ≤ 5 times upper limit of normal (ULN)
  • Creatinine ≤ 2 times ULN
  • PT ≤ 28
  • INR ≤ 2.5
  • No active variceal bleeding within the past 3 months
  • No encephalopathy grade 3-4
  • No ongoing ethanol or intravenous drug abuse
  • Not pregnant or breast feeding


  • See Disease Characteristics
  • Any number of prior therapies (e.g., chemotherapy, resection, embolization, or radiofrequency/ethanol ablation therapy) allowed
  • No concurrent chemotherapy, radiotherapy, or immunotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00257426

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United States, North Carolina
The University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Bert H. O'Neil, MD UNC Lineberger Comprehensive Cancer Center
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Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT00257426    
Other Study ID Numbers: LCCC 0221
CDR0000561597 ( Other Identifier: PDQ number )
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents