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Home > "S" Clinical Trials Conditions > Seocalcitol in Treating Patients With Advanced Hepatocellular Carcinoma  Seocalcitol in Treating Patients With Advanced Hepatocellular Carcinoma
Seocalcitol in Treating Patients With Advanced Hepatocellular Carcinoma
For Condition: recurrent adult primary liver cancer,adult primary hepatocellular carcinoma,advanced adult primary liver cancer
Status: No longer recruiting
Sponsor(s): LEO Pharma ,
Synopsis: RATIONALE: Seocalcitol may help hepatocellular carcinoma (liver cancer) cells develop into normal cells. It is not yet known whether seocalcitol is effective in treating advanced hepatocellular carcinoma. PURPOSE: Randomized phase III trial to determine the effectiveness of seocalcitol in treating patients who have advanced hepatocellular carcinoma.
Details: OBJECTIVES: - Determine the efficacy of seocalcitol, in terms of prolonging survival, in patients with advanced hepatocellular carcinoma not amenable to curative treatment. - Determine the tumor response in patients treated with this drug. - Determine the safety of this drug in these patients. - Determine the quality of life of patients treated with this drug. OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to stage (BCLC stage 0 vs stage 1). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral seocalcitol once daily. - Arm II: Patients receive oral placebo as in arm I. In both arms, treatment continues for 1-6 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, months 1, 3, 6, 9, and 12, and then every 6 months during treatment. Patients with stage 0 disease are followed annually for up to 6 years. Patients with stage I disease are followed annually for up to 4 years. PROJECTED ACCRUAL: Approximately 944 patients (618 stage 0 and 326 stage I; 472 total per treatment arm) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed advanced hepatocellular carcinoma not amenable to curative treatment or transplantation - Barcelona Clinic Liver Cancer (BCLC) stage 0 or I - No Okuda stage III - At least 1 uni- or bidimensionally measurable lesion by CT scan PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - WHO 0-2 Life expectancy - At least 3 months Hematopoietic - WBC at least 1,500/mm^3 - Hemoglobin at least 8.5 g/dL Hepatic - Not specified Renal - Creatinine no greater than 1.5 times upper limit of normal - Calcium less than 5.4 mg/dL - Albumin corrected calcium less than 10.72 mg/dL - No history or concurrent evidence of kidney stones by flat plate of the kidneys, ureter, and bladder or ultrasound within the past 2 weeks Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior or concurrent metabolic disease affecting calcium homeostasis - No other active primary tumor within the past 2 years except basal cell skin cancer or carcinoma in situ of the cervix - No situation that would preclude study compliance (e.g., alcoholism, drug dependence, or psychotic state) PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - More than 2 weeks since prior corticosteroids at more than the equivalent of 25 mg prednisone daily - More than 2 weeks since prior calcitonin Radiotherapy - Not specified Surgery - Not specified Other - More than 2 weeks since prior calcium-lowering therapy (e.g., mithramycin, phosphate, or bisphosphonates) - More than 4 weeks since prior treatment with any other investigational drug - More than 4 weeks since prior anticancer therapy - No prior randomization in this study - No other concurrent anticancer therapy - No concurrent participation in any other therapeutic clinical trial - No concurrent medications known to affect systemic calcium metabolism (e.g., calciferol supplements [greater than 400 IU], vitamin A supplements [greater than 500 IU], calcium supplements, fluoride, or antiepileptics interfering with calciferol metabolism [e.g., phenytoin])
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HanneHvidberg, Study Chair, LEO Pharma
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , 71013
Italy
Policlinico Hospital
Milan, , 20122
Italy
S. Orsola - Malpighi Hospital
Bologna, , 40138
Italy
Istituto Di Science Biomediche San Paolo
Milano, , 20142
Italy
Universita Degli Studi di Firenze - Policlin. di Careggi
Florence, , 50100
Italy
Centre Hospitalier Universitaire de Bicetre
Le Kremlin-Bicetre, , 94270
France
Centre Hospitalier General de Saint Nazaire
Saint-Nazaire, , 44600
France
Heritage Medical Research Clinic
Calgary, Alberta, T2N 4N1
Canada
Ospedale S. Biagio
Clusone - Bergamo, , 24023
Italy
Hopital Notre-Dame de Bon Secours
Metz, , 57038
France
Royal Infirmary
Edinburgh, Scotland, EH3 9YW
United Kingdom
Hospital Universitario Central de Asturias
Oviedo, , 33006
Spain
Hospital de Cruces
Barakaldo - Bilbao, , E-48903
Spain
Hopital Saint Andre
Bordeaux, , 33075
France
Leo Pharma A/S
Ballerup, , DK-2750
Denmark
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Hospital Del Mar
Barcelona, , 08003
Spain
Ospedale Maggiore Ca'Granda
Milan, , 20159
Italy
Hospital General Universitari Vall d'Hebron
Barcelona, , 08035
Spain
C.H.U. de Brest
Brest, , 29200
France
Hospital Clinic y Provincial de Barcelona
Barcelona, , 08036
Spain
Hospital de la Princesa
Madrid, , 28003
Spain
Hospsital de Sabadell
Sabadell, , 08208
Spain
Hospital Ramon y Cajal
Madrid, , 28034
Spain
Additional Information:
Study ID Numbers: CDR0000287011; LEOPHARMA-EBC-9801-INT,EU-20300
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058110
Other Advanced Adult Primary Liver Cancer Studies:
1. Thalidomide Plus Interferon alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
2. TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
3. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
4. DX-8951f in Treating Patients With Liver Cancer
5. Antineoplaston Therapy in Treating Patients With Primary Liver Cancer
Related Studies:
Other advanced adult primary liver cancer Clinical Trials
Other Clinical Trials
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Seocalcitol in Treating Patients With Advanced Hepatocellular Carcinoma
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