An investigation of the traditional algorithm-based designs for phase 1 cancer clinical trials

Drug Information Journal

Volumn 36, Issue 4, 2002, Pages 865-873

  Kang, Seung Ho ^a   Ahn, Chul W ^b  

^a Ewha Womans University   (South Korea)

^b UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

Author keywords

Algorithm based design; Dose finding studies; Maximum tolerated dose; Phase 1 cancer trials; Toxicity

Indexed keywords

ANTINEOPLASTIC AGENT;

ALGORITHM; ARTICLE; CANCER RESEARCH; CLINICAL RESEARCH; CLINICAL TRIAL; DOSE CALCULATION; DRUG DESIGN; DRUG DOSE REGIMEN; DRUG RESEARCH; HUMAN; LETHAL DOSE; MATHEMATICAL COMPUTING; MAXIMUM TOLERATED DOSE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RECEIVER OPERATING CHARACTERISTIC; STATISTICAL MODEL; TOXICITY TESTING;

EID: 0036975813     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150203600415     Document Type: Article

References (12)

1. Kang S, Ann C. The expected toxicity rate at the maximum tolerated dose in the standard phase I cancer clinical trial design. Drug Inf J. 2001;35(4);1189-1200.
2. Lin Y, Shih W. Statistical properties of the traditional algorithm-based designs for phase I cancer clinical trails. Biostatistics. 2001;2:203-215.
3. O'Quigley J, Pepe M, Fisher M. Continual reassessment method: A practical design for phase I clinical trials in cancer. Biometrics. 1990;46:33-48.
4. O'Quigley J, Chevret S. Methods for dose finding studies in cancer trials: A review and results of a Monte Carlo study. Stat Med. 1991;10:1647-1664.
5. Faries D. Practical modifications of the continual reassessment method for phase I cancer clinical trials. J Biopharmaceutical Stat. 1994;4:147-164.
6. Goodman S, Zahurak M, Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med. 1995;14:1149-1161.
7. Moller S. An extension of the continual reassessment methods using a preliminary up-and-down design in a dose finding study in cancer patients, in order to investigate a greater range of doses. Stat Med. 1995;14:911-922.
8. Ahn C. An evaluation of phase I cancer clinical trial designs. Stat Med. 1998;17:1537-1549.
9. Korn E, Midthune D, Chen T, Rubinstein L, Christian M, Simon R. A comparison of two phase I trial designs. Stat Med. 1994;13:1799-1806.
10. Zohar S, Chevret S. The continual reassessment method: comparing of Bayesian stopping rules for dose-ranging studies. Stat Med. 2001;20:2827-2843.
11. Goldsmith M, Slavik M, Carter S. Quantitative prediction of drug toxicity in human from toxicology in small and large animals. Cancer Research. 1975;35:1354-1364.
12. Smith T, Lee J, Kantarjian H, Legha S, Raber M. Design and results of phase I cancer clinical trial: three-year experience at M.D. Anderson Cancer Center. J Clinical Oncology. 1996;14(1):287-295.