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Activity Number:
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457
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 1, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Biometrics Section
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| Abstract - #309087 |
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Title:
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New Phase I Trial Designs for Combinations of Two Agents
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Author(s):
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Shenghua (Kelly) Fan and Alan P. Venook and Ying Lu*+
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Companies:
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California State University, East Bay and University of California, San Francisco and University of California, San Francisco
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Address:
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Department of Radiology, San Francisco, CA, 94143-0946,
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Keywords:
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Phase I trial ; MTD ; DLT ; toxicity ; isotonic ; dose escalation
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Abstract:
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Combination therapy of two anti-tumor agents may provide treatment synergy. Phase I trials search the maximum tolerated dose (MTD) of such combinations. The conventional approach is to pre-select an escalation path, usually increasing dose of one agent and then another, and to use the standard 3+3 procedure. This procedure may miss the optimum dose combination not on the path and prolong the duration to reach the MTD. In this paper, we present a comprehensive search for a two-agent combination therapy. We evaluate algorithms based on dose limiting toxicity (DLT) and combination of DLT and any toxicity in such a search. A two-dimensional isotonic estimation method for toxicity rate will be provided. We use simulation methods to compare 2+1 versus 3+3 algorithms. We conclude that a comprehensive search for MTD for a combination-therapy of two-agents can be practical and efficient.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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