European Journal of Cancer
Volume 44, Issue 1 , Pages 19-24 , January 2008

Endpoints and other considerations in phase I studies of targeted anticancer therapy: Recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies (MDICT)

  • Christopher M. Booth

      Affiliations

    • National Cancer Institute of Canada Clinical Trials Group, 10 Stuart Street, Kingston, ON, Canada K7L 3N6
    • Research Fellow, NCIC Clinical Trials Group.
    • ,
  • A. Hilary Calvert

      Affiliations

    • Northern Institute for Cancer Research, Medical School, Newcastle upon Tyne, UK
    • ,
  • Giuseppe Giaccone

      Affiliations

    • Medical Oncology Branch, National Cancer Institute, Bethesda, USA
    • ,
  • Marinus W. Lobbezoo

      Affiliations

    • NDDO Research Foundation, Amsterdam, The Netherlands
    • ,
  • Lesley K. Seymour

      Affiliations

    • National Cancer Institute of Canada Clinical Trials Group, 10 Stuart Street, Kingston, ON, Canada K7L 3N6
    • ,
  • Elizabeth A. Eisenhauer

      Affiliations

    • National Cancer Institute of Canada Clinical Trials Group, 10 Stuart Street, Kingston, ON, Canada K7L 3N6
    • Corresponding Author InformationCorresponding author: Tel.: +1 613 533 6430; fax: +1 613 533 2941.
    • ,
  • On behalf of the Task Force on Methodology for the Development of Innovative Cancer Therapies

Received 26 July 2007 ,Accepted 31 July 2007.

References 

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  2. Eskens FA, Verweij J. The clinical toxicity profile of vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR) targeting angiogenesis inhibitors: a review. Eur J Cancer. 2006;42(18):3127–3139
  3. Parulekar WR, Eisenhauer EA. Phase I trial design for solid tumor studies of targeted, non-cytotoxic agents: theory and practice. J Natl Cancer Inst. 2004;96(13):990–997
  4. Plourde PV, Dyroff M, Dowsett M, Demers L, Yates R, Webster A. ARIMIDEX: a new oral, once-a-day aromatase inhibitor. J Steroid Biochem Mol Biol. 1995;53(1–6):175–179
  5. Ford HE, Mitchell F, Cunningham D, et al. Patterns of elevation of plasma 2′-deoxyuridine, a surrogate marker of thymidylate synthase (TS) inhibition, after administration of two different schedules of 5-fluorouracil and the specific TS inhibitors raltitrexed (Tomudex) and ZD9331. Clin Cancer Res. 2002;8(1):103–109
  6. Plummer R, Middleton M, Wilson R, et al. First in human phase I trial of the PARP inhibitor AG-014699 with temozolomide (TMZ) in patients (pts) with advanced solid tumors. J Clin Oncol. 2007;23(16S):

PII: S0959-8049(07)00589-8

doi: 10.1016/j.ejca.2007.07.034

European Journal of Cancer
Volume 44, Issue 1 , Pages 19-24 , January 2008

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