Incorporating a Patient Dichotomous Characteristic in Cancer Phase I Clinical Trials Using Escalation with Overdose Control.pdfVIP

Hindawi Publishing Corporation Journal of Probability and Statistics Volume 2012, Article ID 567819, 10 pages doi:10.1155/2012/567819 Research Article Incorporating a Patient Dichotomous Characteristic in Cancer Phase I Clinical Trials Using Escalation with Overdose Control ´ Mourad Tighiouart, Galen Cook-Wiens, and Andre Rogatko Biostatistics and Bioinformatics Research Center, Samuel Oschin Comprehensive Cancer Institute, 8700 Beverly Boulevard, PACT, Suite 900C, Los Angeles, CA 90048, USA Correspondence should be addressed to Mourad Tighiouart, mourad.tighiouart@ Received 29 June 2012; Accepted 5 September 2012 Academic Editor: Yichuan Zhao Copyright q 2012 Mourad Tighiouart et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. We describe a design for cancer phase I clinical trials that takes into account patients heterogeneity thought to be related to treatment susceptibility. The goal is to estimate the maximum tolerated dose MTD given patient’s specific dichotomous covariate value. The design is Bayesian adaptive and is an extension of escalation with overdose control EWOC. We will assess the performance of this method by comparing the following designs via extensive simulations: 1 design using a covariate; patients are accrued to the trial sequentially and the dose given to a patient depends on his/her baseline covariate value, 2 design ignoring the covariate; patients are accrued to the trial sequentially and the dose given to a patient does not depend on his/her baseline covariate value, a