Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

UNC Lineberger Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Conditions

Liver Cancer

Treatments

Drug: octreotide acetate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00257426

CDR0000561597 (Other Identifier)

LCCC 0221

UNC-LCCC-0221

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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