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Clinical Cancer Research Vol. 11, 5342-5346, August 1, 2005
© 2005 American Association for Cancer Research

Perspectives

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

André Rogatko1, James S. Babb2, Mourad Tighiouart1, Fadlo R. Khuri1 and Gary Hudes3

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.




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Copyright © 2005 by the American Association for Cancer Research.