|
Activity Number:
|
54
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Sunday, August 2, 2009 : 4:00 PM to 5:50 PM
|
|
Sponsor:
|
Biometrics Section
|
| Abstract - #304835 |
|
Title:
|
Design of Phase II Cancer Trials for Evaluation of Cytostatic/Cytotoxic Agents
|
|
Author(s):
|
Masha Kocherginsky*+ and Ezra Cohen and Theodore Karrison
|
|
Companies:
|
The University of Chicago and The University of Chicago and The University of Chicago
|
|
Address:
|
5841 South Maryland, Chicago, IL, 60637,
|
|
Keywords:
|
phase 2 clinical trial design ; multinomial response ; stable disease
|
|
Abstract:
|
New anti-cancer agents may have both cytotoxic and cytostatic effects, and assessment of response and stable disease rates may be of interest in early phase clinical trials in order to capture the full impact of such treatments. We describe the design of a single-arm, phase II clinical trial for the simultaneous evaluation of objective response and stable disease (lack of early tumor progression) rates using standard RECIST criteria. A sufficiently high rate of either of these endpoints will lead to rejection of the null hypothesis. A design is chosen to satisfy the type I error constraint and to have sufficient statistical power at several points within the alternative hypothesis space using a restricted search algorithm. An early stopping rule for lack of efficacy is incorporated. The method is illustrated by the design of a phase II clinical trial in head and neck cancer.
|
