This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Rogatko, A. Articles by Hudes, G. Search for Related Content PubMed PubMed Citation Articles by Rogatko, A. Articles by Hudes, G.

New Paradigm in Dose-Finding Trials: Patient-Specific Dosing and Beyond Phase I

Authors' Affiliations: ¹ Winship Cancer Institute, Atlanta, Georgia; ² New York University Medical Center, New York, New York; and ³ Fox Chase Cancer Center, Philadelphia, Pennsylvania

Requests for reprints: André Rogatko, Winship Cancer Institute, Room B4109, 1365-B Clifton Road NE, Atlanta, GA 30322. Phone: 404-778-2696; Fax: 404-778-5016; E-mail: Andre_rogatko{at}emory.org.

We propose a new paradigm for the clinical evaluation of new cancer therapies. It entails adjusting the search for the optimal dose on the basis of measurable patient characteristics that may be predictive of adverse responses to treatment, and extending this search beyond phase I and into phases II and III. We provide examples of (a) how the fine-tuning of dose may involve utilization of patient-specific attributes to obtain a personalized treatment regimen, and (b) how novel methods for phase I design can be used to update the working dose for the conduct of phase II and III cancer clinical trials. These examples should be interpreted as an enticement for the development of new methods to implement the proposed new paradigm.

This article has been cited by other articles:

				A. Rogatko, D. Schoeneck, W. Jonas, M. Tighiouart, F. R. Khuri, and A. Porter Translation of Innovative Designs Into Phase I Trials J. Clin. Oncol., November 1, 2007; 25(31): 4982 - 4986. [Abstract] [Full Text] [PDF]

				L. Gianni Ixabepilone and the Narrow Path to Developing New Cytotoxic Drugs J. Clin. Oncol., August 10, 2007; 25(23): 3389 - 3391. [Full Text] [PDF]