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Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
octreotide acetate
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of North Carolina Lineberger Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Median survival

Secondary Outcome Measures

number of subjects with toxicities
Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0

Full Information

First Posted
November 18, 2005
Last Updated
February 12, 2012
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00257426
Brief Title
Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Official Title
A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
octreotide acetate
Other Intervention Name(s)
Sandostatin
Intervention Description
200mcg,3 times per day, 7 days per week, up to 36 weeks
Primary Outcome Measure Information:
Title
Median survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
number of subjects with toxicities
Description
Toxicities will be graded using the NCI's Common Toxicity Criteria, Version 2.0
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bert H. O'Neil, MD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of North Carolina Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

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