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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 2/2010

01-01-2010 | Original Article

Phase I/II study of the lipiodolization using DDP-H (CDDP powder; IA-call®) in patients with unresectable hepatocellular carcinoma

Authors: Yo-ichi Yamashita, Akinobu Taketomi, Shinji Itoh, Norifumi Harimoto, Kazutoyo Morita, Takasuke Fukuhara, Shigeru Ueda, Kensaku Sanefuji, Keishi Sugimachi, Tsuyoshi Tajima, Yoshihiko Maehara

Published in: Cancer Chemotherapy and Pharmacology | Issue 2/2010

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Abstract

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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Metadata
Title
Phase I/II study of the lipiodolization using DDP-H (CDDP powder; IA-call®) in patients with unresectable hepatocellular carcinoma
Authors
Yo-ichi Yamashita
Akinobu Taketomi
Shinji Itoh
Norifumi Harimoto
Kazutoyo Morita
Takasuke Fukuhara
Shigeru Ueda
Kensaku Sanefuji
Keishi Sugimachi
Tsuyoshi Tajima
Yoshihiko Maehara
Publication date
01-01-2010
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 2/2010
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-009-1034-5

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