Clinical trials of anti-cancer therapies are widely used critically important tools in the search for more effective cancer treatments. Cancer clinical trials typically proceed through effective cancer treatments. Cancer clinical trials typically proceed through several distinct phases. The major objective in phase I trials is to identify a working-dose for subsequent phase II and III studies wherein the major objective is an evaluation of treatment efficacy. We are developing statistical methods to improve the design and analysis of phase I and II clinical trials. To achieve this goal, detailed data from these trials are needed so that the statistical methods in development will be rooted in representative real studies. Although numerous trials are conducted at the Fox Chase Cancer Center (FCCC) in collaboration with different sponsors, the detailed information associated with them is not readily accessible in a format amenable to statistical analyses. This led to an FCCC funded project that created a database with phase I and II trial information The main objective of the present study is to conduct statistical analyses characterizing phase I and II patient populations to identify patient characteristics predictive of treatment response. Specifically, the primary aims of this study are to: Specific Aim 1: Determine risk factors for toxic response to treatment and prognostic factors predictive of clinical or surrogate response to treatment. Provide an assessment of the impact of any statistically significant factors on both the dose recommended for each patient and on the probability of treatment response. Specific Aim 2: Compare patients in phase I and II trials of the same regimen with respect to the significant risk and prognostic factors identified in Aim 1. This will provide an assessment of differences between phase I and II patient populations in terms of susceptibility or responsiveness to treatment as well as the appropriateness of using a dose level determined based on phase I data throughout a phase II trial. Specific Aim 3: To extend the existing database to include additional trials and additional information about clinical and immunologic treatment response for patients already in the database.
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