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Unformatted text preview: Bayesian Methods for Cancer Phase I Clinical Trials 5 Table 1 Dose Level of 5-FU (mg/m2) and Binary
Assessment of Treatment-Induced Toxic Response
for the 12 Patients in the 5-FU Phase I Trial
a 5-FU Dose Response 140
338 No DLT
DLT Patients are listed in chronological order according to date
of accrual. PNU Trial
The incorporation of patient-speciﬁc covariate information into a Bayesian design scheme will be exempliﬁed through a phase I study of PNU214565 (PNU) involving patients with advanced adenocarcinomas of
gastrointestinal origin (Babb and Rogatko, 2001). Previous clinical and
preclinical studies demonstrated that the action of PNU is moderated by
the neutralizing capacity of anti-SEA antibodies. Based on this, the MTD
of PNU was deﬁned as a function of the pretreatment concentration of
circulating anti-SEA antibodies. Speciﬁcally, the MTD was deﬁned as the
dose level expected to induce DLT in a proportion u = .1 of the patients
with a given pretreatment anti-SEA concentration. 2. GENERAL BAYESIAN METHODOLOGY
The design and conduct of phase I clinical trials would beneﬁt from
statistical methods that can incorporate information from preclinical
studies and sources outside the trial. Furthermore, both the investigator Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved. ...
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This note was uploaded on 06/13/2011 for the course PHYSICS 101 taught by Professor Shu during the Spring '11 term at FIU.
- Spring '11