Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas
The purpose of this study is to determine the maximal tolerated dose of idarubicin for chemoembolization of non resectable non metastatic hepatocellular carcinoma.
|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|
- Dose-limiting toxicity assessed according NCI CTC AE v3.0 [ Time Frame: Within the first month after chemoembolization ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||December 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Dose escalation: level0 = idarubicin 5mg, level1 = idarubicin 10mg, level2 = idarubicin 15mg, level3 = idarubicin 20mg, level4 = idarubicin 25mg
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
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.
|Centre Hospitalier Universitaire de DIJON|
|Dijon, Burgundy, France, 21000|
|Principal Investigator:||Laurent BEDENNE, MD Ph.D||Centre Hospitalier Universitaire de DIJON|