The Oncologist, Vol. 8, No. 1, 1–1,
February 2003
© 2003 AlphaMed Press
A Plea for Phase I Clinical Trials
Bruce A. Chabner, M.D., Editor-in-Chief
The Oncologist
At present, there seems to be very little place for traditional phase I trials in first-line oncology journals. Because of the growing interest in the development of targeted drugs and mechanism-based therapies, proof of principle (POP) dominates our thinking about new drugs. In many cases, the POP is little more than enlightened ambiguity. The "targeted agent" has multiple actions, some known and others unknown; which of these is responsible for its effects may never be resolved. Whether the drug works or not is another matter. The result is that the highest priority for publication is given to phase I studies that incorporate translational research: kinase assays on peripheral blood or tumor cells, gene chips, Western blots, positron emission tomography scans, dynamic magnetic resonance imaging, and so forth. All of this is well and good, but is there a place for the less glamorous workhorse, the much maligned, straight forward, dose-escalated phase I study with pharmacokinetics?
The Oncologist will provide that space for well-designed and well-executed phase I studies (such as the one published in the current issue of The Oncologist [1]), including trials of cytotoxics, targeted agents, and biologicals. While the result may not point to a paradigm shift, such papers will give our readership an early exposure to drugs of the next decade. We will not demand POP studies; instead, we will look for a convincing demonstration of a safe dose and schedule, well-executed pharmacokinetics, and an agent with an interesting pedigree. Tell us that it is safe, unique, and biologically not inert, and we will read about it, and maybe even enlist our patients on a phase II trial of the subject drug.
 
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Bruce A. Chabner, M.D.
Editor-in-Chief
The Oncologist
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REFERENCES
- West W, Birch R, Schnell F et al. Phase I study of paclitaxel and topotecan for the first-line treatment of extensive-stage small cell lung cancer. The Oncologist 2003:8:76–82.[Abstract/Free Full Text]
