“Classical 3 + 3 design” versus “accelerated titration designs”: analysis of 270 phase 1 trials investigating anti-cancer agents

Booth CM, Calvert AH, Giaccone G, Lobbezoo MW, Seymour LK, Eisenhauer EA, Task Force on Methodology for the Development of Innovative Cancer Therapies (2008) Eur J Cancer 44:19–24. doi:10.1016/j.ejca.2007.07.034

Morabito A, Di Maio E, Normanno N, Perrone F (2006) Methodology of clinical trials with new molecular-targeted agents: where do we stand? Ann Oncol 17(S7):vii128–vii131. doi:10.1093/annonc/mdl965

Ratain MJ, Mick R, Schilsky R et al (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. doi:10.1093/jnci/85.20.1637

Simon R, Friedlin B, Rubinstein LV, Arbuck SG, Collins J, Christian MC (1997) Accelerated titration designs for phase I clinical trials in oncology. J Natl Cancer Inst 89:1138–1147. doi:10.1093/jnci/89.15.1138

Verweij J (2008) "No risk, no fun": challenges for the oncology phase I clinical trial time-performance. Eur J Cancer 44:2600–2607. doi:10.1016/j.ejca.2008.07.043

Penel N, Vanseymortier M, Bonneterre ME, Clisant S, Dansin E, Vendel Y, Beuscart R, Bonneterre J (2008) Prognostic factors among cancer patients with good performance status screened for phase I trials. Invest New Drugs 26:53–58. doi:10.1007/s10637-007-9088-x

Decoster G, Stein G, Holdener EE (1990) Response and toxic deaths in phase I clinical trials. Ann Oncol 1:175–181

Von Hoff DD, Turner J (1991) Response rates, duration of response and dose response effects in phase I studies. Invest New Drugs 9:115–121

Bachelot T, Ray-Coquard I, Catimel G et al (2000) Multivariate analysis of prognostic factors for toxicity and survival for patients enrolled in phase I clinical trials. Ann Oncol 11:151–156. doi:10.1023/A:1008368319526

Daugherty CK, Ratain HJ, Grochowski E, Stocking C, Kodish E et al (1995) Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13:1062

Agrawal M, Emmanuel EJ (2003) Ethics of phase I oncology studies: re-examining the arguments and the data. JAMA 290:1075–1082. doi:10.1001/jama.290.8.1075

Roberts TG, Goulart BH, Stallings SC et al (2004) Trends in the risk and benefits to patients with participating in phase I clinical trials. JAMA 292:2130–2140. doi:10.1001/jama.292.17.2130

Estey E, Hoth D, Simon R, Marsoni S, Leyland-Jones B, Wittes R (1996) Therapeutic responses in phase I trials of antineoplastic agents. Cancer Treat Rep 70:1105–1115