Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

This study has been terminated.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00051545
First received: January 13, 2003
Last updated: February 21, 2007
Last verified: April 2005
  Purpose

To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma (HCC).


Condition Intervention Phase
Liver Neoplasms
Drug: Seocalcitol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5 ug) or Placebo in Prolonging Time to Relapse Following Intended Curative Resection or Percutaneous Ablative Treatment for Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).

Secondary Outcome Measures:
  • Survival
  • Time to distant recurrence of HCC
  • Time to second primary HCC
  • Time to development of metastases
  • Tumour measurements
  • Tumour marker (alpha-fetoprotein AFP)
  • Quality of life
  • Length of hospital stay
  • Adverse events
  • Laboratory safety examinations
  • Dose of Seocalcitol

Estimated Enrollment: 608
Study Start Date: November 1999
Estimated Study Completion Date: June 2004
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospital in- or out patients
  • Either sex
  • 18 to 75 years of age
  • With hepatocellular carcinoma treated successfully with surgical resection or percutaneous ablative treatment within 4 and 8 weeks, respectively, prior to inclusion.
  • All patients must give their signed informed consent to join the study.

Exclusion Criteria:

  • Patients previously treated with any anti-cancer therapy for HCC except for surgical resection and percutaneous ablative therapy
  • Patients treated with chemotherapy or other anti-cancer therapy (except surgical resection or percutaneous ablative treatment) in the previous 4 weeks
  • Patients with another primary tumor except basocellular carcinoma of the skin or in situ carcinoma of the cervix within the last 2 years
  • With a history of renal stone(s)
  • With a life expectancy < 3 months
  • WHO performance status 3 or 4.
  • Patients with hypercalcemia (ionised serum calcium > 1.35 mmol/l or albumin corrected serum calcium > 2.68 mmol/l), previous/current calcium metabolic disease, taking calcium-lowering therapy or medication known to affect systemic calcium metabolism, or with marked laboratory abnormalities.
  • Patients with recurrent hepatocellular carcinoma, with known extrahepatic metastases, Okuda stage III disease and patients with a Child-Pugh score of C are also excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051545

Locations
Canada, Ontario
E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting)
Toronto, Ontario, Canada, M5G2C4
France
E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France)
Metz, France, F-57038 Metz Cedex
Italy
E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy)
Milano, Italy, I-20 122
Spain
E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)
Barcelona, Spain, E-08036
United Kingdom
E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)
Edinburgh, United Kingdom, EH3 9YW
Sponsors and Collaborators
LEO Pharma
Investigators
Study Director: Hanne Hvidberg, MScPharm PhD LEO Pharma
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00051545     History of Changes
Other Study ID Numbers: EBC 9802 INT
Study First Received: January 13, 2003
Last Updated: February 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by LEO Pharma:
liver
cancer
hepatocellular
carcinoma

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Seocalcitol
Calcitriol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 14, 2014