Homework 2. Due Monday 1 May.
1. The classic Storer design says that you treat 3 patients at dose
i
. If none have doselimiting toxicities
(DLT), you escalate to dose
i
+ 1. If 2 or 3 have DLT, you stop and declare dose
i

1 to be the maximum
tolerated dose (MTD). If 1 has a DLT, you give 3 more patients dose
i
.
If none of those have DLT, you
escalate, but if 1 or more have DLT, you declare dose
i

1 to be the MTD. We worked out in class and you
can find in Piantadosi the probability that you escalate to dose
i
+ 1. (That is, escalate past dose
i
.)
Consider the modified Storer design used in the trial UCD171, where we require six patients to have
been tested before we will declare a dose to be safe. Recall we declare dose
i
not to be safe if we have 2 or
more DLT observed in either 3 or 6 patients at that dose. The modification is that if we have not already
seen 6 patients at dose
i

1, we would have to treat 3 more at that dose before declaring it to be safe. Derive
a formula for the probability of stopping at dose
i
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 Winter '06
 Tsodikov
 Clinical trial, Dose, dLt, Maximum Tolerated Dose, Storer design

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