Some Notable Properties of the Standard Oncology Phase I Design

REFERENCES

• Arbuck , S. G. ( 1996 ). Workshop on Phase I study design: Ninth NCI/EORTC new drug development symposium, Amsterdam, March 12, 1996 . Ann. Oncol. 7 : 567 – 573 .
   Google Scholar
• Babb , J. , Rogatko , A. , Zacks , S. ( 1998 ). Cancer Phase I clinical trials: Efficient dose escalation with overdose control . Stat. Med. 17 : 1103 – 1120 .
   PubMed Web of Science ®Google Scholar
• Durham , S. D. , Flournoy , N. ( 1994 ). Random walks for quantile estimation . In: Gupta , S. S. , Berger , J. O. , eds. Statistical Decision Theory and Related Topics V . New York : Springer , pp. 467 – 476 .
   Google Scholar
• Ivanova , A. , Flournoy , N. , Chung , Y. ( 2007 ). Cumulative cohort design for dose-finding . J. Stat. Plan. Infer. 137 : 2316 – 2327 .
   Web of Science ®Google Scholar
• Ivanova , A. , Montazer-Haghighi , A. , Mohanty , S. G. , Durham , S. D. ( 2003 ). Improved up-and-down designs for Phase I trials . Stat. Med. 22 : 69 – 82 .
   PubMed Web of Science ®Google Scholar
• Ji , Y. , Li , Y. , Bekele , N. ( 2007 ). Dose-finding in Phase I clinical trials based on toxicity probability intervals . Clin. Trials 4 : 235 – 244 .
   PubMed Web of Science ®Google Scholar
• Koyfman , S. A. , Agrawal , M. , Garrett-Mayer , E. , Krohmal , B. , Wolf , E. , Emanuel , E. J. , Gross , C. P. ( 2007 ). Risks and benefits associated with novel Phase 1 oncology trial designs . Cancer 110 : 1115 – 1124 .
   PubMed Web of Science ®Google Scholar
• Leung , D. H. Y. , Wang , Y. G. ( 2001 ). Isotonic designs for Phase I trials . Controlled Clin. Trials 22 : 126 – 138 .
   PubMedGoogle Scholar
• Lin , Y. , Shih , W. J. ( 2001 ). Statistical properties of the traditional algorithm-based designs for Phase I cancer clinical trials . Biostatistics 2 : 203 – 215 .
   PubMedGoogle Scholar
• Omura , G. A. ( 2003 ). Modified Fibonacci search . J. Clin. Oncol. 21 : 3177 .
   PubMed Web of Science ®Google Scholar
• O'Quigley , J. , Pepe , M. , Fisher , L. ( 1990 ). Continual reassessment method: a practical design for Phase I clinical trials in cancer . Biometrics 46 : 33 – 48 .
   PubMed Web of Science ®Google Scholar
• Potter , D. M. ( 2006 ). Phase I studies of chemotherapeutic agents in cancer patients: A review of the designs . J. Biopharm. Stat. 16 : 579 – 604 .
   PubMed Web of Science ®Google Scholar
• Reiner , E. , Paoletti , X. , O'Quigley , J. ( 1999 ). Operating characteristics of the standard Phase I clinical trial design . Comput. Stat. Data Anal. 30 : 303 – 315 .
   Web of Science ®Google Scholar
• Robertson , T. , Wright , F. T. , Dykstra , R. L. ( 1988 ). Order Restricted Statistical Inference . Chichester : Wiley .
   Google Scholar
• Rosenberger , W. F. , Haines , L. M. ( 2002 ). Competing designs for Phase I clinical trials: a review . Stat. Med. 21 : 2757 – 2770 .
   PubMed Web of Science ®Google Scholar
• Smith , T. L. , Lee , J. J. , Kantarjian , H. M. , Legha , S. S. , Raber , M. N. ( 1996 ). Design and results of Phase I cancer clinical trials: Three-year experience at MD Anderson Cancer Center . J. Clin. Oncol. 14 : 287 – 295 .
   PubMed Web of Science ®Google Scholar
• Simon , R. ( 1997 ). Accelerated titration designs for Phase I clinical trials in oncology . J. Natl. Cancer. Inst. 89 : 1138 – 1147 .
   PubMed Web of Science ®Google Scholar
• Storer , B. (1989). Design and analysis of Phase I clinical trials. Biometrics 45:925–937.
   PubMed Web of Science ®Google Scholar
• Storer , B. ( 2001 ). An evaluation of Phase I clinical trial designs in the continuous dose-response setting . Stat. Med. 20 : 2399 – 2408 .
   PubMed Web of Science ®Google Scholar
• Stylianou , M. , Flournoy , N. ( 2002 ). Dose finding using the biased coin up-and-down design and isotonic regression . Biometrics 58 : 171 – 177 .
   PubMed Web of Science ®Google Scholar
• Sun , J. ( 1998 ). Interval censoring . Encyclopedia of Biostatistics . New York : John Wiley & Sons Ltd ., pp. 2090 – 2095 .
   Google Scholar