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CompletedNCT00257426Updated Feb 14, 2012

Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

A Phase 2 interventional study of octreotide acetate in Liver Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-14.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Liver Cancer

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Keywords

  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's enrollment of 31 is below the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Interventions

  • Drugoctreotide acetate

    200mcg,3 times per day, 7 days per week, up to 36 weeks

    Also known as: Sandostatin

06

What researchers measure

Primary outcomes

  1. Median survival

    Time frame: 6 months

Secondary outcomes

  1. number of subjects with toxicities

    Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0

    Time frame: 6 months

07

Study locations

1 site
  • The University of North Carolina Lineberger Comprehensive Cancer Center
    Chapel Hill, North Carolina 27599, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00257426
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 22, 2005
Start date
Jul 2005
Primary completion
Feb 2007
Completion
Sep 2009
Last update
Feb 14, 2012

Study contacts

Bert H. O'Neil, MD
principal investigator · UNC Lineberger Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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