Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

February 12, 2012 updated by: UNC Lineberger Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Liver Cancer

Intervention / Treatment

Drug: octreotide acetate

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - The University of North Carolina Lineberger Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median survival Time Frame: 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of subjects with toxicities Time Frame: 6 months	Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Bert H. O'Neil, MD, UNC Lineberger Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

November 18, 2005

First Submitted That Met QC Criteria