Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas

Carcinoma, Hepatocellular Clinical Trial

Official title:

Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040559
• Other study ID #: IDASPHERE
• Status: Completed
• Phase: Phase 1
• First received: December 28, 2009
• Last updated: January 8, 2013
• Start date: December 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de DIJON	Dijon	Burgundy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity assessed according NCI CTC AE v3.0		Within the first month after chemoembolization	Yes
Secondary	Objective responses according criteria of the European Association for the Study of the Liver and according RECIST criteria.		2 months	No
Secondary	Quality of life (EORTC QLQ-C30)		2 months	No
Secondary	Pharmacokinetics parameters of idarubicin and idarubicinol		Within 72 hours after chemioembolization	No