Clinical trial NCT00051532: Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
Official title: Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5ug) or Placebo in the Treatment of Patients With Hepatocellular Carcinoma Not Amenable to Curative Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Neoplasms
Keywords: hepatocellular
carcinoma
liver
cancer
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2003-01-14
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: OTHER

Brief summary: The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma \[HCC\]).


Eligibility criteria: Inclusion Criteria:

* Hospital in- or out-patients
* Either sex
* Aged 18-75 years
* With hepatocellular carcinoma, verified by histology/cytology, which is not amenable to curative treatment or transplantation.
* Patients must have measurable disease, and be classifiable as to Barcelona Clinic Liver Cancer (BCLC) stage 0, as described in Llovet JM et al. Hepatology 1999;29:62-67.

Exclusion Criteria:

* Patients treated with chemotherapy or other anti-cancer therapy within 4 weeks before visit 1
* Patients with another primary tumor, except for basocellular carcinoma of the skin or in situ carcinoma of the cervix, within the last 2 years
* A history of renal stone(s)
* A life expectancy of \< 3 months
* World Health Organization (WHO) performance status 3 or 4
* Okuda stage III.
* Patients with hypercalcemia, or other clinically important laboratory abnormalities
* Patients with previous/current calcium metabolic disease, taking calcium-lowering therapy, or medication known to affect systemic calcium metabolism are also excluded.
* All patients must give their signed informed consent to join the study.

Primary outcomes:
measure: Overall survival, defined as the time from start of treatment to death
Secondary outcomes:
measure: HCC-specific survival from start of treatment
measure: Time to response from start of treatment (complete or partial response)
measure: Proportion of patients who achieve partial/complete response
measure: Time to progression measured from start of treatment
measure: Duration of complete response in patients showing a complete response, measured from the first date when absence of disease was recorded until the first date of disease progression was recorded
measure: Duration of partial response in patients showing partial response, measured from first date when partial response was recorded until the first date at which disease progression was observed
measure: Duration of stable disease measured from start of treatment until the first date where either progression or partial/complete response was observed
measure: Change(s) in tumour size
measure: Change in tumour marker
measure: Number of days of hospitalisation (in-patient care)
measure: Quality of life
measure: Adverse events
measure: Change in laboratory values
measure: Dose of seocalcitol (seocalcitol treated patients)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)
state: Alberta
city: Metz
country: France
facility: E.g. Notre-Dame de Bon Secours, Service d´Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)
city: Milano
country: Italy
facility: E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)
city: Barcelona
country: Spain
facility: E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)
city: Edinburgh
country: United Kingdom
facility: E.g. The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)
Study officials:
affiliation: LEO Pharma
name: Hanne Hvidberg, MSc Pharm, PhD
role: STUDY_DIRECTOR
References: