TY - JOUR
T1 - Phase I/II study of the lipiodolization using DDP-H (CDDP powder; IA-call®) in patients with unresectable hepatocellular carcinoma
AU - Yamashita, Yo Ichi
AU - Taketomi, Akinobu
AU - Itoh, Shinji
AU - Harimoto, Norifumi
AU - Morita, Kazutoyo
AU - Fukuhara, Takasuke
AU - Ueda, Shigeru
AU - Sanefuji, Kensaku
AU - Sugimachi, Keishi
AU - Tajima, Tsuyoshi
AU - Maehara, Yoshihiko
PY - 2010/1
Y1 - 2010/1
N2 - Purpose: Lipiodol Ultra-Fluid (Lipiodol®), an oily contrast medium, is selectively retained in hepatocellular carcinoma (HCC) through hepatic arterial infusion. DDP-H (IA-call®) developed as a CDDP powder, and may be a possible chemotherapeutic agent with lipiodol. We carried out a phase I/II study of the lipiodolization using DPP-H in patients with unresectable HCC. Methods: Phase I and pharmacokinetic study: The dose-limiting toxicity (DLT), the maximum tolerance dose (MTD), and the recommended dose (RD) were determined using a modified Fibonacci scheme. The concentration-time profile of total platinum in plasma was analyzed. Phase II study: Thirty-five patients with unresectable HCC received lipiodolization using DDP-H under RD, and the efficacy and safety were assessed. Results: DLT was grade 3 vomiting at 40 mg/m2. Therefore, MTD and RD were 35 mg/m2. The peak of total platinum in plasma was over 1.0 μg/ml at 40 mg/m2 at 30 min after infusion. Of the 35 patients, 16 (45.7%) demonstrated complete responses, and 4 (11.4%) demonstrated partial responses with an additional 9 patients (25.7%) having stable diseases, as assessed by RECIST. Grade 3 thrombocytopenia was found in 1 patient (2.9%), grade 2 hyperbilirubinemia was found in 2 patients (5.7%), and grade 2 vomiting was found in 4 patients (11.4%). Conclusion: Lipiodolization using DDP-H at 35 mg/m2 is effective and well tolerated in patients with unresectable HCC.
AB - Purpose: Lipiodol Ultra-Fluid (Lipiodol®), an oily contrast medium, is selectively retained in hepatocellular carcinoma (HCC) through hepatic arterial infusion. DDP-H (IA-call®) developed as a CDDP powder, and may be a possible chemotherapeutic agent with lipiodol. We carried out a phase I/II study of the lipiodolization using DPP-H in patients with unresectable HCC. Methods: Phase I and pharmacokinetic study: The dose-limiting toxicity (DLT), the maximum tolerance dose (MTD), and the recommended dose (RD) were determined using a modified Fibonacci scheme. The concentration-time profile of total platinum in plasma was analyzed. Phase II study: Thirty-five patients with unresectable HCC received lipiodolization using DDP-H under RD, and the efficacy and safety were assessed. Results: DLT was grade 3 vomiting at 40 mg/m2. Therefore, MTD and RD were 35 mg/m2. The peak of total platinum in plasma was over 1.0 μg/ml at 40 mg/m2 at 30 min after infusion. Of the 35 patients, 16 (45.7%) demonstrated complete responses, and 4 (11.4%) demonstrated partial responses with an additional 9 patients (25.7%) having stable diseases, as assessed by RECIST. Grade 3 thrombocytopenia was found in 1 patient (2.9%), grade 2 hyperbilirubinemia was found in 2 patients (5.7%), and grade 2 vomiting was found in 4 patients (11.4%). Conclusion: Lipiodolization using DDP-H at 35 mg/m2 is effective and well tolerated in patients with unresectable HCC.
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U2 - 10.1007/s00280-009-1034-5
DO - 10.1007/s00280-009-1034-5
M3 - Article
C2 - 19495755
AN - SCOPUS:71349086841
SN - 0344-5704
VL - 65
SP - 301
EP - 307
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
IS - 2
ER -
