Abstract |
In spite of the large number of nutrient-derived agents demonstrating promise as potential chemopreventive agents, most have failed to prove effectiveness in clinical trials. Critical requirements for moving nutrient-derived agents to recommendation for clinical use include adopting a systematic, molecular-mechanism based approach and utilizing the same ethical and rigorous methods such as are used to evaluate other pharmacological agents. Preliminary data on a mechanistic rationale for chemoprevention activity as observed from epidemiological, in vitro and preclinical studies, phase I data of safety in suitable cohorts, duration of intervention based on time to progression of preneoplastic disease to cancer and the use of a valid panel of biomarkers representing the hypothesized carcinogenesis pathway for measuring efficacy must inform the design of phase II clinical trials. The goal of this paper is to provide a model for evaluating a well characterized agent- Polyphenon E- in a phase II clinical trial of prostate cancer chemoprevention.
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Authors | Nagi Kumar, Theresa Crocker, Tiffany Smith, Shahnjayla Connors, Julio Pow-Sang, Philippe E Spiess, Kathleen Egan, Gwen Quinn, Michael Schell, Said Sebti, Aslam Kazi, Tian Chuang, Raoul Salup, Mohamed Helal, Gregory Zagaja, Edouard Trabulsi, Jerry McLarty, Tajammul Fazili, Christopher R Williams, Fred Schreiber, Kyle Anderson |
Journal | Journal of clinical trials
(J Clin Trials)
Vol. 2
Issue 1
(Jan 21 2012)
ISSN: 2167-0870 [Print] United States |
PMID | 24533253
(Publication Type: Journal Article)
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