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

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