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Phase I/II study of irinotecan plus infusional 5-fluorouracil/leucovorin (FOLFIRI) in Japanese patients with advanced colorectal cancer and genetic testing for UDP-glucuronosyltransferase (UGT) 1A1*28 and *6.

Research Project

Project/Area Number 20590546
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeSingle-year Grants
Section一般
Research Field Applied pharmacology
Research InstitutionSaitama Medical University

Principal Investigator

NAGASHIMA Fumio  Saitama Medical University, 医学部, 客員准教授 (70348209)

Co-Investigator(Renkei-kenkyūsha) SASAKI Yasutsuna  埼玉医科大学, 医学部, 教授 (20235279)
FUJITA Keniti  埼玉医科大学, 医学部, 講師 (60281820)
Project Period (FY) 2008 – 2010
Project Status Completed (Fiscal Year 2010)
Budget Amount *help
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2010: ¥130,000 (Direct Cost: ¥100,000、Indirect Cost: ¥30,000)
Fiscal Year 2009: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2008: ¥4,030,000 (Direct Cost: ¥3,100,000、Indirect Cost: ¥930,000)
Keywordsヒト組織利用研究 / 臨床薬理学 / ゲノム薬理学 / イリノテカン / UGT1A1 / 薬物動態 / 遺伝子多型 / 個別化医療 / 大腸癌 / 副作用 / 塩酸イリノテカン / 用量調節試験 / UGTIA1 / ABCC2
Research Abstract

This phase I/II study demonstrates that the recommended doses of irinotecan and infusional 5-fluorouracil in FOLFIRI for Japanese patients with advanced colorectal cancer who do not possess the UDP-glucuronosyltransferase 1A1*28 allele are 180 and 2400mg/m^2, respectively. Toxicities occurring at the recommended doses are manageable in these patients.

Report

(4 results)
  • 2010 Annual Research Report   Final Research Report ( PDF )
  • 2009 Annual Research Report
  • 2008 Annual Research Report
  • Research Products

    (25 results)

All 2011 2010 2009 2008

All Journal Article (11 results) (of which Peer Reviewed: 9 results) Presentation (10 results) Book (4 results)

  • [Journal Article] Phase I/II study of FOLFIRI in Japanese patients with advanced colorectal cancer.2011

    • Author(s)
      Yamashita K, Nagashima F, Fujita K, Yamamoto W, Endo H, Miya T, Narabayashi M, Kawara K, Akiyama Y, Ando Y, Ando M, Sasaki Y.
    • Journal Title

      Jpn J Clin Oncol 41

      Pages: 204-209

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Phase I/II study of FOLFIRI in Japanese patients with advanced colorectal cancer.2011

    • Author(s)
      Yamashita Keishi
    • Journal Title

      Jpn J Clin Oncol

      Volume: 41 Pages: 204-209

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Delayed elimination of SN-38 in cancer patients with severe renal failure.2011

    • Author(s)
      Fujita Ken-ichi
    • Journal Title

      Drug Metab Dispos

      Volume: 31 Pages: 161-164

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] UGT1A1*1/*28 and *1/*6 genotypes have no effects on the efficacy and toxicity of FOLFIRI in Japanese patients with advanced colorectal cancer.2010

    • Author(s)
      Sunakawa Y, Ichikawa W, Fujita KI, Nagashima F, Ishida H, Yamashita K, Mizuno K, Miwa K, Kawara K, Akiyama Y, Araki K, Yamamoto W, Miya T, Narabayashi M, Ando Y, Hirose T, Saji S, Sasaki Y.
    • Journal Title

      Cancer Chemother Pharmacol in press

    • Related Report
      2010 Final Research Report
  • [Journal Article] UGT1A1^*1/^*28 and ^*1/^*6 genotypes have no effects on the efficacy and toxicity of FOLFIRI in Japanese patients with advanced colorectal cancer.2010

    • Author(s)
      Sunakawa Yu
    • Journal Title

      Cancer Chemother Pharmacol

      Volume: (in press)

    • Related Report
      2010 Annual Research Report
    • Peer Reviewed
  • [Journal Article] 大腸がん診療におけるバイオマーカー―ゲノム薬理学的視点から―2010

    • Author(s)
      長島文夫
    • Journal Title

      がん分子標的治療 8

      Pages: 46-50

    • Related Report
      2009 Annual Research Report
  • [Journal Article] Naチャネル遺伝子多型と神経障害予測による大腸癌薬物療法の新しい投与法の開発2010

    • Author(s)
      佐々木康綱
    • Journal Title

      埼玉医科大学雑誌 36

      Pages: 125-127

    • Related Report
      2009 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Association of ATP-binding cassette, sub-family C, number 2 (ABCC2) genotype with pharmacokinetics of irinotecan in Japanese patients with metastatic colorectal cancer treated with irinotecan plus infusional 5-fluorouracil/leucovorin (FOLFIRI).2008

    • Author(s)
      Fujita K, Nagashima F, Yamamoto W, Endo H, Sunakawa Y, Yamashita K, Ishida H, Mizuno K, Matsunaga M, Araki K, Tanaka R, Ichikawa W, Miya T, Narabayashi M, Akiyama Y, Kawara K, Ando Y, Sasaki Y.
    • Journal Title

      Biol Pharm Bull 31

      Pages: 2137-2142

    • NAID

      110006968101

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Genetic testing for UGT1A1*28 and *6 in Japanese patients who receive irinotecan chemotherapy.2008

    • Author(s)
      Akiyama Y, Fujita K, Nagashima F, Yamamoto W, Endo H, Sunakawa Y, Yamashita K, Ishida H, Mizuno K, Araki K, Ichikawa W, Miya T, Narabayashi M, Kawara K, Sugiyama M, Hirose T, Ando Y, Sasaki Y.
    • Journal Title

      Ann Oncol 19

      Pages: 2089-2090

    • Related Report
      2010 Final Research Report
    • Peer Reviewed
  • [Journal Article] Association of ATP-binding cassette, sub-family C, number 2(ABCC2) genotype with pharmacokinetics of irinotecan in Japanese patients with metastatic colorectal cancer treated with irinotecan plus infusional 5-fluorouracil/leucovorin (FOLFIRI).2008

    • Author(s)
      藤田健一
    • Journal Title

      Biol Pharm Bull. 31

      Pages: 2137-2142

    • NAID

      110006968101

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Genetic testing for UGT1A1*28 and *6 in Japanese patients who receive irinotecan chemotherapy.2008

    • Author(s)
      秋山祐子
    • Journal Title

      Ann Oncol. 19

      Pages: 2089-2090

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Presentation] Genetic testing of UGT1A1^*28 and ^*6 to select FOLFIRI or FOLFOX as first-line therapy for advanced colorectal cancer.2010

    • Author(s)
      石田博雄
    • Organizer
      第69回日本癌学会学術総会
    • Place of Presentation
      大阪
    • Year and Date
      2010-09-24
    • Related Report
      2010 Annual Research Report
  • [Presentation] 切除不能結腸直腸癌に対するFOLFIRI療法の効果・毒性とUGT1A1*28および*6の関連性2008

    • Author(s)
      砂川優
    • Organizer
      日本癌治療学会総会
    • Place of Presentation
      名古屋
    • Year and Date
      2008-10-31
    • Related Report
      2010 Final Research Report 2008 Annual Research Report
  • [Presentation] FOLFIRIを投与した日本人結腸・直腸がん患者におけるABCC2遺伝子多型とイリノテカンの体内動態の関係2008

    • Author(s)
      秋山裕子
    • Organizer
      日本癌学会総会
    • Place of Presentation
      名古屋
    • Year and Date
      2008-10-29
    • Related Report
      2010 Final Research Report 2008 Annual Research Report
  • [Presentation] 大腸癌患者に対する5-FU+1-ロイコボリン+塩酸イリノテカン併用療法(FOLFIRI)の第I/II相試験とABCC2の遺伝薬理学的解析2008

    • Author(s)
      藤田健一
    • Organizer
      日本癌学会総会
    • Place of Presentation
      名古屋
    • Year and Date
      2008-10-29
    • Related Report
      2010 Final Research Report
  • [Presentation] 転移再発大腸がん患者に対する5-FU+1-ロイコボリン+塩酸イリノテカン併用療法(FOLFIRI)の第I/II相試験とABCC2の遺伝薬理学的解析2008

    • Author(s)
      長島文夫
    • Organizer
      日本癌学会総会
    • Place of Presentation
      名古屋
    • Year and Date
      2008-10-29
    • Related Report
      2008 Annual Research Report
  • [Presentation] An update of a phase I/II trial of FOLFIRI for colorectal cancer patients with pharmacogenetic/pharmacokinetic analysis.2008

    • Author(s)
      山下啓史
    • Organizer
      36^<th> Congress of the International Society of Oncology and Biomarkers
    • Place of Presentation
      東京
    • Year and Date
      2008-10-09
    • Related Report
      2010 Final Research Report 2008 Annual Research Report
  • [Presentation] Association of ABCC2 genotype with pharmacokinetics of irinotecan in Japanese patients with metastatic colorectal cancer treated with FOLFIRI.2008

    • Author(s)
      藤田健一
    • Organizer
      米国癌学会(AACR)総会
    • Place of Presentation
      サンディエゴ
    • Year and Date
      2008-04-15
    • Related Report
      2010 Final Research Report
  • [Presentation] A phase I/II study and pharmacokinetic study of irinotecan in combination with 5-FU/leucovorine (FOLFIRI) in Japanese patients with metastatic colorectal cancer and the role of UGT1A1 polymorphisms.2008

    • Author(s)
      長島文夫
    • Organizer
      米国癌学会(AACR)総会
    • Place of Presentation
      サンディエゴ
    • Year and Date
      2008-04-15
    • Related Report
      2010 Final Research Report
  • [Presentation] Association of ABCC2 genotype with pharmacokinetics of irinotecan in Japanese patients with metastatic colorectal cancer treated with FOLFIRI.2008

    • Author(s)
      藤田健一
    • Organizer
      米国癌学会(AACR)総会
    • Place of Presentation
      米国サンディエゴ
    • Year and Date
      2008-04-15
    • Related Report
      2008 Annual Research Report
  • [Presentation] A phase I/II study and pharmacokinetic study of irinotecan in combination with 5-FU/leucovorine (FOLFIRI) in Japanese patients with metastatic colorectal cancer and the role of UGT1A1 polymorphisms.2008

    • Author(s)
      長島文夫
    • Organizer
      米国癌学会(AACR)総会
    • Place of Presentation
      米国サンディエゴ
    • Year and Date
      2008-04-13
    • Related Report
      2008 Annual Research Report
  • [Book] 個別化医療(抗ガン剤の安全性・副作用予測手法と薬物動態・遺伝子多型を指標とした投与量の調節法)2011

    • Author(s)
      長島文夫、廣川智、北村浩、古瀬純司
    • Publisher
      株式会社技術情報協会
    • Related Report
      2010 Final Research Report
  • [Book] 個別化医療2011

    • Author(s)
      長島文夫
    • Total Pages
      320
    • Publisher
      株式会社技術情報協会
    • Related Report
      2010 Annual Research Report
  • [Book] 消化器研修ノート(標準的化学療法)2009

    • Author(s)
      長島文夫、古瀬純司
    • Publisher
      診断と治療社
    • Related Report
      2010 Final Research Report
  • [Book] 消化器研修ノート2009

    • Author(s)
      長島文夫
    • Total Pages
      4
    • Publisher
      診断と治療社
    • Related Report
      2009 Annual Research Report

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Published: 2008-04-01   Modified: 2016-04-21  

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