NCT01040559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 9, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

December 28, 2009

Last Update Submit

January 8, 2013

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

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

    Within the first month after chemoembolization

Secondary Outcomes (3)

  • Objective responses according criteria of the European Association for the Study of the Liver and according RECIST criteria.

    2 months

  • Quality of life (EORTC QLQ-C30)

    2 months

  • Pharmacokinetics parameters of idarubicin and idarubicinol

    Within 72 hours after chemioembolization

Study Arms (1)

Idarubicin

EXPERIMENTAL

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

Drug: idarubicin

Interventions

idarubicinDRUG

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

Also known as: 4-MDR, IMI 30, IDA
Idarubicin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de DIJON

Dijon, Burgundy, 21000, France

Location

Related Publications (2)

  • 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.

    PMID: 27342239DERIVED

  • 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.

    PMID: 24738629DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Idarubicin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Laurent BEDENNE, MD Ph.D

    Centre Hospitalier Universitaire Dijon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2009

First Posted

December 29, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

January 9, 2013

Record last verified: 2013-01

Locations

FR(1)