Liver Cancer
Conditions
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
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.
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.
Interventions
DRUGoctreotide acetate
200mcg,3 times per day, 7 days per week, up to 36 weeks
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median survival | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of subjects with toxicities | 6 months | Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0 |
Countries
United States
Outcome results
None listed