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Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01040559
First received: December 28, 2009
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Carcinoma, Hepatocellular
 Drug: idarubicin
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Dose-limiting toxicity assessed according NCI CTC AE v3.0 [ Time Frame: Within the first month after chemoembolization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective responses according criteria of the European Association for the Study of the Liver and according RECIST criteria. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Quality of life (EORTC QLQ-C30) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics parameters of idarubicin and idarubicinol [ Time Frame: Within 72 hours after chemioembolization ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: December 2009
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040559

Locations
France
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 de DIJON
  More Information

No publications provided

Responsible Party: Professor Laurent Bedenne, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01040559     History of Changes
Other Study ID Numbers: IDASPHERE
Study First Received: December 28, 2009
Last Updated: January 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Idarubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013