Practical implementation of a modified continual reassessment method for dose-finding trials

Cancer Chemotherapy and Pharmacology

Volumn 41, Issue 6, 1998, Pages 429-436

  Piantadosi, S ^a,b   Fisher, J D ^a   Grossman, S ^a  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b NABTT CNS Consortium   (United States)

Author keywords

9AC; Continual reassessment method; Glioblastoma; Phase I trials; Standard method (SM)

Indexed keywords

9 AMINOCAMPTOTHECIN; ANTICONVULSIVE AGENT; CAMPTOTHECIN DERIVATIVE; CYTOTOXIC AGENT;

ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; COMPUTER PROGRAM; CONTROLLED STUDY; DOSE CALCULATION; DOSE RESPONSE; GLIOBLASTOMA; HUMAN; MATHEMATICAL MODEL; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RECURRENT CANCER; RELIABILITY; TECHNIQUE; TOXICITY;

ANTINEOPLASTIC AGENTS; BRAIN NEOPLASMS; CAMPTOTHECIN; CLINICAL TRIALS, PHASE I; DOSE-RESPONSE RELATIONSHIP, DRUG; GLIOBLASTOMA; HUMANS; MODELS, THEORETICAL; NEOPLASM RECURRENCE, LOCAL; REPRODUCIBILITY OF RESULTS;

EID: 0031888716     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s002800050763     Document Type: Article

References (16)

1. 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
2. Korn EL, Midthune D, Chen TT, Rubinstein LV, Christian MC, Simon RM (1994) A comparison of two phase 1 trial designs. Stat Med 13: 1799-1806
3. Goodman SN, Zahurak ML, Piantadosi S (1995) Some practical improvements in the continual reassessment method for phase I studies. Stat Med 14: 1149-1161
4. Dixon WJ, Mood AM (1948) A method for obtaining and analysing sensitivity data. J Am Stat Assoc 43: 109-126
5. Wetherill GB (1963) Sequential estimation of quantal response curves (with discussion). J R Soc Stat B 25: 1-48
6. Storer BE (1989) Design and analysis of phase I clinical trials. Biometrics 45: 925-937
7. Robbins H, Monro S (1951) A stochastic approximation method. Ann Math Stat 22: 400-407
8. Wong WK, Lachenbruch PA (1996) Designing studies for dose response. Stat Med 15: 343-359
9. Ruberg SJ (1995) Dose response studies. I. Some design considerations. J Biopharm Stat 5: 1-14
10. Ruberg SJ (1995) Dose response studies, II. Analysis and interpretation. J Biopharm Stat 5: 15-42
11. Ratain MJ, Mick R, Schilsky RL, Siegler M (1993) Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents. J Natl Cancer Inst 85: 1637-1643
12. Piantadosi S, Liu G (1996) Improved designs for phase I studies using pharmacokinetic measurements. Stat Med 15: 1605-1618
13. Piantadosi S (1997) Clinical trials: a methodologic perspective. John Wiley & Sons, New York
14. Rubin E, Wood V, Bharti A, et al (1994) A phase I trial of 9-aminocamptothecin (9-AC). Proc Am Assoc Cancer Res 35: 245
15. Grossman SA, Hochberg F, Fisher J, Chen TL, Kim L, Gregory R, Grochow LB, Piantadosi S, for the NABTT CNS Consortium (1997) Increased 9-aminocamptothecin dose requirements in patients on anticonvulsants. Proc Am Soc Clin Oncol 16: 389a
16. Wolfram S (1996) The mathematica book, 3rd edn. Wolfram Media and Cambridge University Press, Cambridge