The overall objective of this proposal is to conduct phase I clinical trials of investigational anticancer agents.
The specific aims are to; 1) Define the acute toxicities of new anticancer agents in patients with advanced cancer. 2) Provide information on the pharmacologic characteristics (absorption, distribution, metabolism and elimination) of selected antitumor agents; 3) Define treatment regimens for evaluation of antitumor activity in phase II trials; 4) Redefine the acute toxicities and pharmacokinetics of existing anticancer agents administered in combination with colony-stimulating factors and other toxicity-ameliorating agents, which may facilitate the exploration of more effective doses and schedules; 5) Use pharmacologic characteristics to establish appropriate phase II doses on special patient populations (such as geriatric populations and those with impaired end-end-organ function or those with heavy pretreatment) and to explore pharmacokinetic and pharmacodynamic differences based on gender, age, or ethnic groups; 6) Obtain preliminary information on pharmacokinetic/pharmacodynamic correlations which can be extended in phase II trials; and 7) Incorporate ancillary basic laboratory studies to enhance our understanding of the biochemical and/or biological mechanism(s) of drug action. To accomplish these specific aims, we will accrue up to 50 patients per year to approximately 3 active phase I trials. All clinical trials will be conducted in accordance with instructions in the CTEP Investigators's Handbook. All data will be submitted to the National Cancer Institute on a weekly basis. It is projected that this effort will help the National Cancer Institute achieve its goals of developing new agents to treat patients with cancer.
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