A Bayesian evaluation of enrolling additional patients at the maximum tolerated dose in Phase I trials

Contemporary Clinical Trials

Volumn 26, Issue 2, 2005, Pages 131-140

  Gönen, Mithat ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

Dose escalation; Dose limiting toxicity; Posterior density

Indexed keywords

ARTICLE; BAYES THEOREM; CALCULATION; COHORT ANALYSIS; DOSE RESPONSE; HUMAN; MATHEMATICAL COMPUTING; MAXIMUM TOLERATED DOSE; MEDICAL INFORMATION;

BAYES THEOREM; CLINICAL TRIALS, PHASE I; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG EVALUATION; DRUG TOXICITY; HUMANS; MAXIMUM TOLERATED DOSE; MODELS, STATISTICAL; PATIENT SELECTION; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN;

EID: 18844419240     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2004.12.007     Document Type: Article

References (19)

1. M.E. Buyse, M.J. Staquet, and R.J. Sylvester Cancer clinical trials: methods and practice 1984 Oxford University Press Oxford
2. S. Piantadosi Clinical trials: a methodologic perspective 1997 John Wiley and Sons New York
3. S. Green, J. Benedetti, and J. Crowley Clinical trials in oncology Second ed. 2003 Chapman and Hall New York
4. B.E. Storer Choosing a Phase I design J. Crowley Handbook of statistics in clinical oncology 2001 Marcel Dekker New York 73 92
5. E.A. Eisenhauer, P.J. O'Dwyer, M. Christian, and J.S. Humphrey Phase I clinical trial design in cancer drug development J. Clin. Oncol. 18 2000 684 692
6. D.H. Leung, and Y. Wang Isotonic designs for Phase I trials Control Clin. Trials 22 2001 126 138
7. D.H. Leung, and Y.G. Wang An extension of the continual reassessment method using decision theory Stat. Med. 21 2002 51 63
8. S.N. Goodman, M.L. Zahurak, and S. Piantadosi Some practical improvements in the continual reassessment method for Phase I studies Stat. Med. 14 1995 1149 1161
9. J. O'Quigley Curve-free and model-based continual reassessment method designs Biometrics 58 2002 245 249
10. J. O'Quigley Another look at two Phase I clinical trial designs Stat. Med. 18 1999 2683 2690 [discussion 2691-2]
11. J. O'Quigley Estimating the probability of toxicity at the recommended dose following a Phase I clinical trial in cancer Biometrics 48 1992 853 862
12. J. O'Quigley, and S. Chevret Methods for dose finding studies in cancer clinical trials: a review and results of a Monte Carlo study Stat. Med. 10 1991 1647 1664
13. J. O'Quigley, M. Pepe, and L. Fisher Continual reassessment method: a practical design for Phase 1 clinical trials in cancer Biometrics 46 1990 33 48
14. J. O'Quigley, and L.Z. Shen Continual reassessment method: a likelihood approach Biometrics 52 1996 673 684
15. M. Gasparini, and J. Eisele A curve-free method for Phase I clinical trials Biometrics 56 2000 609 615
16. J. Babb, A. Rogatko, and S. Zacks Cancer Phase I clinical trials: efficient dose escalation with overdose control Stat. Med. 17 1998 1103 1120
17. N. Kemeny, W. Tong, and M. Gonen Phase I study of weekly oxaliplatin plus irinotecan in previously treated patients with metastatic colorectal cancer Ann. Oncol. 13 2002 1490 1496
18. B.P. Carlin, and T.A. Louis Bayes and empirical Bayes methods for data analysis Second ed. 2000 Chapman & Hall New York
19. A. Gelman, J.B. Carlin, H.S. Stern, and D.B. Rubin Bayesian data analysis 1995 Chapman and Hall London