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Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Completed
CT.gov ID
NCT01040559
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
30
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
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 :
Dec 1, 2009
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dose-limiting toxicity assessed according NCI CTC AE v3.0 [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. [2 months]

    2. Quality of life (EORTC QLQ-C30) [2 months]

    3. Pharmacokinetics parameters of idarubicin and idarubicinol [Within 72 hours after chemioembolization]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Universitaire de DIJON Dijon Burgundy France 21000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire Dijon

    Investigators

    • Principal Investigator: Laurent BEDENNE, MD Ph.D, Centre Hospitalier Universitaire Dijon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01040559
    Other Study ID Numbers:
    • IDASPHERE
    First Posted:
    Dec 29, 2009
    Last Update Posted:
    Jan 9, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Idarubicin

    Study Results

    No Results Posted as of Jan 9, 2013