Page 371 - Withrow and MacEwen's Small Animal Clinical Oncology, 6th Edition
P. 371

CHAPTER 18  Clinical Trials and Developmental Therapeutics  349


           advocate and advance the use and utility of veterinary oncology     23.   Barnard  RA, Wittenburg  LA, Amaravadi RK, et  al.: Phase I
           clinical trials. The field of veterinary oncology will continue to   clinical trial and pharmacodynamic evaluation of combina-
                                                                    tion hydroxychloroquine and doxorubicin treatment in pet
           grow through the proper use and design of both traditional and
  VetBooks.ir  novel clinical trial designs.                        dogs treated for spontaneously occurring lymphoma, Autophagy
                                                                    10:1415–1425, 2014.
           References                                              24.   Gray R, Manola J, Saxman S, et al.: Phase II clinical trial design:
                                                                    methods in translational research from the Genitourinary Commit-
                                                                    tee at the Eastern Cooperative Oncology Group, Clin Cancer Res
             1.   Thamm DH, Vail DM: Veterinary oncology clinical trials: design   12:1966–1969, 2006.
              and implementation, Vet J 205:226–232, 2015.         25.   Lee JJ, Feng L: Randomized phase II designs in cancer clinical trials:
             2.   Vail DM: Cancer clinical trials: development and implementation,   current status and future directions, J Clin Oncol 23:4450–4457,
              Vet Clin North Am Small Anim Pract 37:1033–1057, 2007.  2005.
             3.   Potter DM: Phase I studies of chemotherapeutic agents in cancer     26.   Brown  SR,  Gregory WM, Twelves  CJ, et  al.: Designing phase
              patients: a review of the designs, J Biopharm Stat 16:579–604, 2006.  II trials in cancer: a systematic review and guidance, Br J Cancer
             4.   Kummar S, Gutierrez M, Doroshow JH, et al.: Drug development   105:194–199, 2011.
              in oncology: classical cytotoxics and molecularly targeted agents, Br     27.   Michaelis  LC,  Ratain  MJ:  Phase  II trials  published  in  2002: a
              J Clin Pharmacol 62:15–26, 2006.                      cross-specialty comparison showing significant design differences
             5.   Acevedo PV, Topmeyer DL, Rubin EH: Phase I trial design and   between oncology trials and other medical specialties, Clin Cancer
              methodology for anticancer drugs. In Teicher BA, Andrews PA, edi-  Res 13:2400–2405, 2007.
              tors: Anticancer Drug Development Guide, ed 2, Totowa, NJ, 2004,     28.   Simon R: Optimal two-stage designs for phase II clinical trials, Con-
              Humana Press, pp 351–362.                             trol Clin Trials 10:1–10, 1989.
             6.   Khanna  C, Lindblad-Toh K, Vail  D, et  al.: The dog as a cancer     29.   Ocana A, Tannock IF: When are “positive” clinical trials in oncology
              model, Nat Biotechnol 24:1065–1066, 2006.             truly positive?, J Natl Cancer Inst 103:16–20, 2011.
             7.   Paoloni M, Khanna C: Translation of new cancer treatments from     30.   Mandrekar SJ, Sargent DJ: Randomized phase II trials: time for a
              pet dogs to humans, Nat Rev Cancer 8:147–156, 2008.   new era in clinical trial design, J Thorac Oncol 5:932–934, 2010.
             8.   LeBlanc AK, Mazcko CN, Khanna C: Defining the value of a com-    31.   Eisenhauer EA, Therasse P, Bogaerts J, et al.: New response evalu-
              parative approach to cancer drug development,  Clin Cancer Res   ation criteria in solid tumours: revised RECIST guideline (version
              22:2133–2138, 2016.                                   1.1), Eur J Cancer 45:228–247, 2009.
             9.   Le Tourneau C, Lee JJ, Siu LL: Dose escalation methods in phase I     32.   Jaffe CC: Measures of response: RECIST, WHO, and new alterna-
              cancer clinical trials, J Natl Cancer Inst 101:708–720, 2009.  tives, J Clin Oncol 24:3245–3251, 2006.
             10.   Vail D: Veterinary Co-operative Oncology Group—Common Ter-    33.   Gomez-Roca  C, Koscielny S,  Ribrag V, et  al.:  Tumour growth
              minology Criteria for Adverse Events (VCOG-CTCAE) following   rates and RECIST criteria in early drug development, Eur J Cancer
              chemotherapy or biological antineoplastic therapy in dogs and cats   47:2512–2516, 2011.
              v1.1, Vet Comp Oncol 10:1–30, 2011.                  34.   Nguyen  SM, Thamm DH, Vail  DM, et  al.: Response evaluation
             11.   Ishizuka N, Ohashi Y: The continual reassessment method and its   criteria for solid tumours in dogs (v1.0): a Veterinary Cooperative
              applications: a Bayesian methodology for phase I cancer clinical tri-  Oncology Group (VCOG) consensus document,  Vet Comp Onc
              als, Stat Med 20:2661–2681, 2001.                     13:176–183, 2015.
             12.   Zohar S, Chevret S: Phase I (or phase II) dose-ranging clinical trials:     35.   Rasmussen F: RECIST and targeted therapy, Acta Radiol 50:835–
              proposal of a two-stage Bayesian design, J Biopharm Stat 13:87–101,   836, 2009.
              2003.                                                36.   Rosen MA: Use of modified RECIST criteria to improve response
             13.   Hanson AR, Graham DM, Pond GR, et al.: Phase 1 trial design: is   assessment in targeted therapies: challenges and opportunities, Can-
              3+3 best? Cancer Control 21:200–208, 2014.            cer Biol Ther 9:20–22, 2010.
             14.   Wong KM, Capasso A, Eckhardt SG: The changing landscape of     37.   Gutierrez ME, Kummar S, Giaccone G: Next generation oncology
              phase I trials in oncology, Nat Rev Clin Oncol 13:106–117, 2016.  drug development: opportunities and challenges, Nat Rev Clin Oncol
             15.   Bria E, Di Maio M, Carlini P, et al.: Targeting targeted agents:   6:259–265, 2009.
                                                                                                         th
              open issues for clinical trial design,  J Exp Clin Cancer Res 28:     38.   Hoos A, Wolchok JD, Humphrey RW, et al.: CCR 20  Anniversary
              66, 2009.                                             commentary: immune-related response criteria – capturing clinical
             16.   Brunetto AT, Kristeleit RS, de Bono JS: Early oncology clinical trial   activity in immune-oncology, Clin Cancer Res 21:4989–4991, 2015.
              design in the era of molecular-targeted agents, Future Oncol 6:1339–    39.   Wolchok JD, Hoos A, O’Day S, et al.: Guidelines for the evalua-
              1352, 2010.                                           tion of immune therapy activity in solid tumors: immune-related
             17.   Hoekstra R, Verweij J, Eskens FA: Clinical trial design for target   response criteria, Clin Cancer Res 15:7412–7420, 2009.
              specific anticancer agents, Invest New Drugs 21:243–250, 2003.    40.   Burton JH, Mitchell L, Thamm DH, et al.: Low-dose cyclophospha-
             18.   Parulekar WR, Eisenhauer EA: Phase I trial design for solid tumor   mide selectively decreases regulatory T cells and inhibits angiogen-
              studies of targeted, non-cytotoxic agents: theory and practice, J Natl   esis in dogs with soft tissue sarcoma, J Vet Intern Med 25:920–926,
              Cancer Inst 96:990–997, 2004.                         2011.
             19.   Dowlati A, Manda S, Gibbons J, et al.: multi-institutional phase I     41.   Poirier VJ, Thamm DH, Kurzman ID, et al.: Liposome-encapsulated
              trials of anticancer agents, J Clin Oncol 26:1926–1931, 2008.  doxorubicin (Doxil) and doxorubicin in the treatment of vaccine-
             20.   Pryer  NK, Lee LB, Zadovaskaya R, et  al.: Proof of target for   associated sarcoma in cats, J Vet Intern Med 16:726–731, 2002.
              SU11654: inhibition of KIT phosphorylation in canine mast cell     42.   Kinders R, Parchment RE, Ji J, et al.: Phase 0 clinical trials in can-
              tumors, Clin Cancer Res 9:5729–5734, 2003.            cer drug development: from FDA guidance to clinical practice, Mol
             21.   Honigberg LA, Smith AM, Sirisawad M, et al.: The Bruton tyrosine   Interv 7:325–334, 2007.
              kinase inhibitor PCI-32765 blocks B-cell activation and is effica-    43.   Kummar  S, Kinders R, Rubinstein L, et  al.: Compressing drug
              cious in models of autoimmune disease and B-cell malignancy, Proc   development timelines in oncology using phase ‘0’ trials, Nat Rev
              Natl Acad Sci USA 107:13075–13080, 2010.              Cancer 7:131–139, 2007.
             22.   Wittenburg LA, Gustafson DL, Thamm DH: Phase I pharmacoki-    44.   Murgo AJ, Kummar S, Rubinstein L, et al.: Designing phase 0 can-
              netic and pharmacodynamic evaluation of combined valproic acid/  cer clinical trials, Clin Cancer Res 14:3675–3682, 2008.
              doxorubicin treatment in dogs with spontaneous cancer, Clin Cancer     45.   Hulley SB, Cummings SR, Browner WS, et al.: Designing Clinical
              Res 16:4832–4842, 2010.                               Research, Philadelphia, 2007, Lippincott Williams & Wilkins.
   366   367   368   369   370   371   372   373   374   375   376