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Logo of bmcgastBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Gastroenterology
 
BMC Gastroenterol. 2012; 12: 127.
Published online Sep 20, 2012. doi:  10.1186/1471-230X-12-127
PMCID: PMC3482551
Phase I study of miriplatin combined with transarterial chemotherapy using CDDP powder in patients with hepatocellular carcinoma
Kenya Kamimura,1 Takeshi Suda,corresponding author1 Yasushi Tamura,1 Masaaki Takamura,1 Takeshi Yokoo,1 Masato Igarashi,1 Hirokazu Kawai,1 Satoshi Yamagiwa,1 Minoru Nomoto,1 and Yutaka Aoyagi1
1Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan
corresponding authorCorresponding author.
Kenya Kamimura: kenya-k/at/med.niigata-u.ac.jp; Takeshi Suda: suda/at/med.niigata-u.ac.jp; Yasushi Tamura: ytamura/at/me.niigata-u.ac.jp; Masaaki Takamura: atmc/at/me.niigata-u.ac.jp; Takeshi Yokoo: tal/at/me.niigata-u.ac.jp; Masato Igarashi: ikachu/at/me.niigata-u.ac.jp; Hirokazu Kawai: kawaih/at/me.niigata-u.ac.jp; Satoshi Yamagiwa: syamagi/at/me.niigata-u.ac.jp; Minoru Nomoto: mnomoto/at/me.niigata-u.ac.jp; Yutaka Aoyagi: aoy/at/me.niigata-u.ac.jp
Received May 14, 2012; Accepted September 17, 2012.
Abstract
Background
There is no standard therapeutic procedure for the hepatocellular carcinoma (HCC) in patients with poor hepatic reserve function. With the approval of newly developed chemotherapeutic agent of miriplatin, we have firstly conducted the phase I study of CDDP powder (DDP-H) and miriplatin combination therapy and reported its safety and efficacy for treating unresectable HCC in such cases. To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for the combination of transarterial oily chemoembolization (TOCE) and transarterial chemotherapy (TAC) using miriplatin and DDP-H for treating unresectable hepatocellular carcinoma (HCC).
Methods
Transarterial chemotherapy using DDP-H was performed through the proper hepatic artery targeting the HCC nodules by increasing the dose of DDP-H (35–65 mg/m2) followed by targeting the HCC nodules by transarterial oily chemoembolization with miriplatin.
Results
A total of nine patients were enrolled in this study and no DLT was observed with any dose of DDP-H in all cases in whom 80 mg (median, 18–120) miriplatin was administered. An anti-tumour efficacy rating for partial response was obtained in one patient, while a total of four patients (among eight evaluated) showed stable disease response, leading to 62.5% of disease control rate. The pharmacokinetic results showed no further increase in plasma platinum concentration following miriplatin administration.
Conclusion
Our results suggest that a combination of DDP-H and miriplatin can be safely administered up to their respective MTD for treating HCC.
Trial registration
This study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR000003541).
Keywords: Miriplatin, Hepatocellular carcinoma, Cisplatin powder, Phase I clinical trial
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