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Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma

Primary Purpose

Advanced Hepatocellular Carcinoma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Octreotide
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, Octreotide

Eligibility Criteria

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

Inclusion Criteria: > 18 years HCC diagnosis : histologically or cytologically proven HCC or association of the three following criteria: cirrhosis typical measurable mass (> 3cm, by 2 methods) serum alpha-foetoprotein (AFP) ≥500 µg/L Cancer Liver Italian Program (CLIP) score : 0 to 3 Not eligible for specific treatment (surgery, percutaneous ablation or chemo-embolization) Exclusion Criteria: Glycemia > 2.5 g/L or hypoglycemia Extra hepatic life-threatening disease Serum creatinin> 120 µmol/L Prothrombin time < 50 % Platelet count < 50.000 /µL Symptomatic cholelithiasis Non-measurable tumor

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Octreotide

    Arm Description

    Outcomes

    Primary Outcome Measures

    Overall Survival

    Secondary Outcome Measures

    Objective response
    Survival without progression
    Digestive bleeding
    Renal insufficiency
    Quality of life
    · Safety

    Full Information

    First Posted
    October 14, 2005
    Last Updated
    April 11, 2016
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00241020
    Brief Title
    Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
    Official Title
    Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2002 (undefined)
    Primary Completion Date
    October 2005 (Actual)
    Study Completion Date
    October 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an increasing incidence in industrialized countries. For patients with advanced HCC no efficient treatment is currently available. The objective of this study is to assess the efficacy and safety of octreotide in patients with advanced hepatocellular carcinoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Hepatocellular Carcinoma
    Keywords
    hepatocellular carcinoma, Octreotide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    N/A
    Enrollment
    270 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Octreotide
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Octreotide
    Primary Outcome Measure Information:
    Title
    Overall Survival
    Secondary Outcome Measure Information:
    Title
    Objective response
    Title
    Survival without progression
    Title
    Digestive bleeding
    Title
    Renal insufficiency
    Title
    Quality of life
    Title
    · Safety

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: > 18 years HCC diagnosis : histologically or cytologically proven HCC or association of the three following criteria: cirrhosis typical measurable mass (> 3cm, by 2 methods) serum alpha-foetoprotein (AFP) ≥500 µg/L Cancer Liver Italian Program (CLIP) score : 0 to 3 Not eligible for specific treatment (surgery, percutaneous ablation or chemo-embolization) Exclusion Criteria: Glycemia > 2.5 g/L or hypoglycemia Extra hepatic life-threatening disease Serum creatinin> 120 µmol/L Prothrombin time < 50 % Platelet count < 50.000 /µL Symptomatic cholelithiasis Non-measurable tumor
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma

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