Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Cancer

Intervention / Treatment
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* Drug: octreotide acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: octreotide acetate|200mcg,3 times per day, 7 days per week, up to 36 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median survival |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects with toxicities | Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer