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

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

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12 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)301-307
Number of pages7
JournalCancer chemotherapy and pharmacology
Volume65
Issue number2
DOIs
Publication statusPublished - Jan 2010

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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    Yamashita, Y. I., Taketomi, A., Itoh, S., Harimoto, N., Morita, K., Fukuhara, T., Ueda, S., Sanefuji, K., Sugimachi, K., Tajima, T., & Maehara, Y. (2010). Phase I/II study of the lipiodolization using DDP-H (CDDP powder; IA-call®) in patients with unresectable hepatocellular carcinoma. Cancer chemotherapy and pharmacology, 65(2), 301-307. https://doi.org/10.1007/s00280-009-1034-5