The superiority of the time-to-event continual reassessment method to the rolling six design in pediatric oncology Phase i trials

Clinical Trials

Volumn 8, Issue 4, 2011, Pages 361-369

  Zhao, Lili ^a   Lee, Julia ^b   Mody, Rajen ^b   Braun, Thomas M ^b  

^a UNIVERSITY OF MICHIGAN COMPREHENSIVE CANCER CENTER   (United States)

^b UNIVERSITY OF MICHIGAN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BORTEZOMIB; IRINOTECAN;

ARTICLE; CHILDHOOD CANCER; CLINICAL RESEARCH; DRUG EXPOSURE; HUMAN; MAXIMUM TOLERATED DOSE; MONTE CARLO METHOD; MOTIVATION; MULTIPLE CYCLE TREATMENT; NEUROBLASTOMA; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RECURRENT CANCER; ROLLING SIX DESIGN; SIMULATION; STUDY DESIGN; TIME TO EVENT CONTINUAL REASSESSMENT METHOD;

ADOLESCENT; ALGORITHMS; ANTINEOPLASTIC AGENTS; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS, PHASE I AS TOPIC; HUMANS; INFANT; MEDICAL ONCOLOGY; MONTE CARLO METHOD; MULTICENTER STUDIES AS TOPIC; NEOPLASMS; PATIENT SELECTION; PEDIATRICS; RESEARCH DESIGN; YOUNG ADULT;

EID: 80051703068     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774511407533     Document Type: Article

References (21)

1. Dixon WJ, Mood AM. A method for obtaining and analyzing sensitivity data. J Am Stat Assoc. 1948 ; 43: 109-26
2. Ivanova A. Escalation, group and A + B designs for dose-finding trials. Stat Med. 2006 ; 25: 3668-78 (Pubitemid 44613901)
3. Lin Y, Shih WJ. Statistical properties of the traditional algorithm-based designs for phase I cancer clinical trials. Biostatistics. 2001 ; 2: 203-15
4. Skolnik JM, Barrett JS, Jayaraman B, et al. Shortening the timeline of pediatric phase I trials: the rolling six designs. J Clin Oncol. 2008 ; 26: 190-95
5. Hartford C, Volchenboum SL, Cohn SL. 3 + 3 ≈ (Rolling) 6. J Clin Oncol. 2008 ; 26: 170-71
6. O'Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase I clinical trials in cancer. Biometrics. 1990 ; 46: 33-48 (Pubitemid 20245604)
7. Garrett-Mayer E. The continual reassessment method for dose-finding studies: a tutorial. Clin Trails. 2006 ; 3: 57-71
8. Faries D. Practical modifications of the continual reassessment method for phase I cancer clinical trials. J Biopharm Stat. 1994 ; 4: 147-64 (Pubitemid 24248939)
9. Goodman SN, Zahurak ML, Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med. 1995 ; 14: 1149-61
10. Ahn C. An evaluation of phase I cancer clinical trial designs. Stat Med. 1998 ; 17: 1537-49 (Pubitemid 28367836)
11. Storer BE. An evaluation of Phase I clinical trial designs in the continuous dose-response setting. Stat Med. 2001 ; 20: 2399-408 (Pubitemid 32782709)
12. Korn E, Midthune D, Chen T, et al. A comparison of two phase I trial designs. Stat Med. 1994 ; 13: 1799-806
13. Onar A, Kocak M, Boyett JM. Continual reassessment method vs traditional empirically-based design: modifications motivated by phase I trials in pediatric oncology by the pediatric brain tumor consortium. J Biopharm Stat. 2009 ; 19: 437-55
14. Cheung K, Chappell R. Sequential designs for phase I clinical trials with late-onset toxicities. Biometrics. 2000 ; 56: 1177-82
15. Paoletti X, Kramar A. A comparison of model choices for the continual reassessment method in phase I cancer trials. Stat Med. 2009 ; 28: 3012-28
16. Shen L, O'Quigley JO. Consistency of continual reassessment method under model misspecification. Biometrika. 1996 ; 83: 395-405
17. Braun T. Generalizing the TITE-CRM to adapt for early- and late-onset toxicities. Stat Med. 2005 ; 25: 2071-83 (Pubitemid 43950280)
18. Muler JH, McGinn CJ, Normolle D, et al. Phase I trial using a time-to-event continual reassessment strategy for dose escalation of cisplatin combined with gemcitabine and radiation therapy in pancreatic cancer. J Clin Oncol. 2004 ; 22: 238-43 (Pubitemid 41095087)
19. de Lima M, Giralt S, Thall PF, et al. Maintenance therapy with low-dose azacitidine after allogeneic hematopoietic stem cell transplantation for relapsed AML or MDS: a dose and schedule finding study. J Clin Oncol. 2010 ; 116: 5320-31
20. Normolle D, Lawrence T. Designing dose escalation trials with late onset toxicities using the time-to-event continual reassessment method. J Clin Oncol. 2006 ; 24: 4426-33 (Pubitemid 46630980)
21. Onar-Thomas A, Xiong Z. A simulation-based comparison of the traditional method, rolling-6 design and a frequentist version of the continual reassessment method with special attention to trial duration in pediatric phase I oncology trials. Contemp Clin Trails. 2010 ; 31: 259-70