Phase III Clinical Trials with Anticancer Agents

作者: Wendy R. Parulekar , Daniel J. Sargent

DOI: 10.1007/978-1-4419-7358-0_7

关键词:

摘要: The primary objective of a phase III clinical trial is to demonstrate or confirm the therapeutic benefit new treatment strategy when compared with an alternate treatment, usually current standard care. Due modest incremental benefits seen most anticancer agents, studies generally require large sample sizes and considerable resource allocation. Thus, decision conduct study must be carefully considered. Comprehensive pharmacokinetic pharmacodynamic supporting data should present, including preclinical information regarding absorption, distribution, metabolism, excretion different dosing schedules as well drug interactions any ethnic/gender specific differences in these parameters. Pharmacodynamic interest includes on toxicity antitumor activity. traditional measure activity has been tumor response measured by standardized criteria such RECIST [1]. While shrinkage was frequently considered adequate for cytotoxic chemotherapy, it may not entirely appropriate solid tumors difficult radiological endpoints prostate ovarian cancer molecularly targeted agents whose main mechanism action described cytostatic rather than cytocidal. Additional signals have proposed changes serum marker levels [2, 3] measures progression rates [4, 5] risk [6] Research validate other ongoing.

参考文章(67)
Kotzin S, Overbeke Aj, Marusic A, Hoey J, Horton R, Drazen Jm, Laine C, Van Der Weyden Mb, Schroeder Tv, De Angelis C, Haug C, Frizelle Fa, Sox Hc, Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Croatian Medical Journal. ,vol. 45, pp. 531- ,(2004)
C. Bokemeyer, I. Bondarenko, J. T. Hartmann, F. G. De Braud, C. Volovat, J. Nippgen, C. Stroh, I. Celik, P. Koralewski, KRAS status and efficacy of first-line treatment of patients with metastatic colorectal cancer (mCRC) with FOLFOX with or without cetuximab: The OPUS experience Journal of Clinical Oncology. ,vol. 26, pp. 4000- 4000 ,(2008) , 10.1200/JCO.2008.26.15_SUPPL.4000
M A Smith, R S Ungerleider, E L Korn, L Rubinstein, R Simon, Role of independent data-monitoring committees in randomized clinical trials sponsored by the National Cancer Institute. Journal of Clinical Oncology. ,vol. 15, pp. 2736- 2743 ,(1997) , 10.1200/JCO.1997.15.7.2736
Daniel J. Sargent, Barbara A. Conley, Carmen Allegra, Laurence Collette, Clinical Trial Designs for Predictive Marker Validation in Cancer Treatment Trials Journal of Clinical Oncology. ,vol. 23, pp. 2020- 2027 ,(2005) , 10.1200/JCO.2005.01.112
Adrián V. Hernández, Eric Boersma, Gordon D. Murray, J. Dik F. Habbema, Ewout W. Steyerberg, Subgroup analyses in therapeutic cardiovascular clinical trials: are most of them misleading? American Heart Journal. ,vol. 151, pp. 257- 264 ,(2006) , 10.1016/J.AHJ.2005.04.020
Colin B. Begg, Boris Iglewicz, A treatment allocation procedure for sequential clinical trials. Biometrics. ,vol. 36, pp. 81- 90 ,(1980) , 10.2307/2530497
E. L. Kaplan, Paul Meier, Nonparametric Estimation from Incomplete Observations Springer Series in Statistics. ,vol. 53, pp. 319- 337 ,(1992) , 10.1007/978-1-4612-4380-9_25
C.D. DeAngelis, J.M. Drazen, F.A. Frizelle, C. Huang, J. Hoey, R. Horton, S. Kotzin, C. Laine, A. Marusic, A.J.P.M. Overbeke, T.V. Schroeder, H.C. Sox, M.B. Van Der Weyden, Is this clinical trial fully registered? A statement from the international committee of medical journal editors The New England Journal of Medicine. ,vol. 140, pp. 2436- 2438 ,(2005) , 10.1016/J.AJO.2005.07.004