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Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
idarubicin
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de DIJON

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Idarubicin

Arm Description

Dose escalation: level0 = idarubicin 5mg, level1 = idarubicin 10mg, level2 = idarubicin 15mg, level3 = idarubicin 20mg, level4 = idarubicin 25mg

Outcomes

Primary Outcome Measures

Dose-limiting toxicity assessed according NCI CTC AE v3.0

Secondary Outcome Measures

Objective responses according criteria of the European Association for the Study of the Liver and according RECIST criteria.
Quality of life (EORTC QLQ-C30)
Pharmacokinetics parameters of idarubicin and idarubicinol

Full Information

First Posted
December 28, 2009
Last Updated
January 8, 2013
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01040559
Brief Title
Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas
Official Title
Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Idarubicin
Arm Type
Experimental
Arm Description
Dose escalation: level0 = idarubicin 5mg, level1 = idarubicin 10mg, level2 = idarubicin 15mg, level3 = idarubicin 20mg, level4 = idarubicin 25mg
Intervention Type
Drug
Intervention Name(s)
idarubicin
Other Intervention Name(s)
4-MDR, IMI 30, IDA
Intervention Description
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
Primary Outcome Measure Information:
Title
Dose-limiting toxicity assessed according NCI CTC AE v3.0
Time Frame
Within the first month after chemoembolization
Secondary Outcome Measure Information:
Title
Objective responses according criteria of the European Association for the Study of the Liver and according RECIST criteria.
Time Frame
2 months
Title
Quality of life (EORTC QLQ-C30)
Time Frame
2 months
Title
Pharmacokinetics parameters of idarubicin and idarubicinol
Time Frame
Within 72 hours after chemioembolization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent BEDENNE, MD Ph.D
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de DIJON
City
Dijon
State/Province
Burgundy
ZIP/Postal Code
21000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27342239
Citation
Anota A, Boulin M, Dabakuyo-Yonli S, Hillon P, Cercueil JP, Minello A, Jouve JL, Paoletti X, Bedenne L, Guiu B, Bonnetain F. An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial: idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma. BMJ Open. 2016 Jun 24;6(6):e010696. doi: 10.1136/bmjopen-2015-010696.
Results Reference
derived
PubMed Identifier
24738629
Citation
Boulin M, Hillon P, Cercueil JP, Bonnetain F, Dabakuyo S, Minello A, Jouve JL, Lepage C, Bardou M, Wendremaire M, Guerard P, Denys A, Grandvuillemin A, Chauffert B, Bedenne L, Guiu B. Idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma: results of the IDASPHERE phase I trial. Aliment Pharmacol Ther. 2014 Jun;39(11):1301-13. doi: 10.1111/apt.12746. Epub 2014 Apr 16.
Results Reference
derived

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Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas

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