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

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ClinicalTrials.gov Identifier: NCT00241020
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Advanced Hepatocellular Carcinoma Drug: Octreotide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
Study Start Date : June 2002
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Octreotide Drug: Octreotide



Primary Outcome Measures :
  1. Overall Survival

Secondary Outcome Measures :
  1. Objective response
  2. Survival without progression
  3. Digestive bleeding
  4. Renal insufficiency
  5. Quality of life
  6. · Safety


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241020


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00241020     History of Changes
Other Study ID Numbers: CSMS995BFR04
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
hepatocellular carcinoma
Octreotide

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents