[生物书合集].Advances.in.Clinical.TBiostatisti

[生物书合集].Advances.in.Clinical.TBiostatisti

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3.6. Designs for Drug Combinations In the development of a new cancer therapy, the treatment regimen under investigation will often consist of two or more agents whose levels are to be determined by phase I testing. In such contexts, a simple approach is to conduct the trial in stages with the level of only one agent escalated in each stage. The methods described above can then be implemented to design each stage. An example of this is given by the 5-FU trial. Example: 5-FU Trial (continued) The protocol of the 5-FU trial actually included two separate stages of dose escalation. In the first stage, outlined above, 12 patients were each administered a dose combination consisting of 20 mg/m 2 leucovorin, 0.5 mg/m 2 topotecan, and a dose of 5-FU determined by the EWOC algo- rithm. In the second stage, the level of 5-FU was held fixed at 310 mg/m 2 , corresponding to the dose recommended for the next (i.e., thirteenth) patient had the first stage been allowed to continue. An additional 12
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