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

Phase 2
18 Years
Not Enrolling
Liver Cancer

Thank you

Trial Information

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



- 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.

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median survival

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Bert H. O'Neil, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

LCCC 0221



Start Date:

July 2005

Completion Date:

September 2009

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



The University of North Carolina Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  27599