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Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01040559
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : January 9, 2013
Information provided by:
Centre Hospitalier Universitaire Dijon

Brief Summary:
The purpose of this study is to determine the maximal tolerated dose of idarubicin for chemoembolization of non resectable non metastatic hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: idarubicin Phase 1

Detailed Description:

Hepatocellular carcinoma (HCC) is the fifth most common malignancy and the third most common cause of cancer-related death worldwide. Most of the patients are diagnosed at intermediate-advanced stage when the sole standard treatment is transarterial chemoembolization (TACE). In the literature, survival rates in TACE studies vary widely and finally, there is no suggestion for the best chemotherapeutic agent or the optimal treatment regimen.

We hypothesise that the use of idarubicin (the most cytotoxic drug on HCC cell lines) in DC Bead would enhance the efficacy of TACE. The primary objective of the study is to determine the maximal tolerated dose of idarubicin in DC Bead for chemoembolization of non resectable non metastatic hepatocellular carcinoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial
Study Start Date : December 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Idarubicin
Dose escalation: level0 = idarubicin 5mg, level1 = idarubicin 10mg, level2 = idarubicin 15mg, level3 = idarubicin 20mg, level4 = idarubicin 25mg
Drug: idarubicin
Transarterial chemoembolization (in the hepatic artery) with idarubicin 5mg or 10 mg or 15 mg or 20 mg or 25 mg injected in a solution of 2ml DC Bead (300 µm-500µm); 1 unique course
Other Names:
  • 4-MDR
  • IMI 30
  • IDA

Primary Outcome Measures :
  1. Dose-limiting toxicity assessed according NCI CTC AE v3.0 [ Time Frame: Within the first month after chemoembolization ]

Secondary Outcome Measures :
  1. Objective responses according criteria of the European Association for the Study of the Liver and according RECIST criteria. [ Time Frame: 2 months ]
  2. Quality of life (EORTC QLQ-C30) [ Time Frame: 2 months ]
  3. Pharmacokinetics parameters of idarubicin and idarubicinol [ Time Frame: Within 72 hours after chemioembolization ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Hepatocellular carcinoma cytologically or histologically proved or diagnosed according the criteria of the American Association for the Study of Liver Diseases(AASLD 2005)
  • Three nodules maximum (unilobar disease without limitation in the number of nodules; 3 maximum nodules if bilobar disease [satellite nodules <1cm not included in the total sum])
  • Child-Pugh score A or B7
  • ECOG Performance Status < 2
  • Platelet count > 50,000/µl and absolute neutrophil count (ANC) >1,000/µl
  • Serum creatinine < 150 µmol/l
  • Resting ejection fraction > 50% (echocardiography or isotopic method)
  • Age > 18 years
  • Signed written informed consent

Exclusion Criteria:

  • Patients eligible for surgical resection or hepatic transplantation or radiofrequency ablation
  • Extrahepatic metastases
  • Known gastrointestinal bleeding up to 30 days before study entry
  • Patients with anticoagulant treatment
  • Evidence of portal vein thrombosis
  • Pregnancy
  • Clinically serious infection
  • Known hypersensitivity to anthracyclines
  • Known hypersensitivity to contrast medium

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 identifier (NCT number): NCT01040559

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Centre Hospitalier Universitaire de DIJON
Dijon, Burgundy, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Principal Investigator: Laurent BEDENNE, MD Ph.D Centre Hospitalier Universitaire Dijon

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor Laurent Bedenne, Centre Hospitalier Universitaire Dijon Identifier: NCT01040559     History of Changes
Other Study ID Numbers: IDASPHERE
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: January 9, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action