Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

NCT ID: NCT00257426

Last Updated: 2012-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2009-09-30

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.

Conditions

Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

octreotide acetate

200mcg,3 times per day, 7 days per week, up to 36 weeks

Intervention Type: DRUG

Other Intervention Names

Sandostatin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bert H. O'Neil, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

The University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

UNC-LCCC-0221

Identifier Type: -

Identifier Source: secondary_id

CDR0000561597

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC 0221

Identifier Type: -

Identifier Source: org_study_id