Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Octreotide

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