Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma - Full Text View

Sponsor:	LEO Pharma
Information provided by:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00051545

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 III

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:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: EB 1089

U.S. FDA Resources

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

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:

Click here for more information about this study: Drug Development, Pipeline, Seocalcitol This link exits the ClinicalTrials.gov site

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
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012