Memorial Sloan-Kettering Cancer Center (MSKCC) and its investigators submit this proposal to perform timely high quality clinical Phase II/III trials of anticancer agents including when possible and appropriate correlative laboratory studies. MSKCC is particularly able to complete high priority trials requiring rapid patient accrual to answer pressing questions of national and internation import in the treatment of patients with cancer. In addition, our clinical trials include the performance of correlative biological studies including pharmacokinetic and pharmacodynamic analysis of new agents and crucially obtaining tissue for analysis of biological markers. Nor counting our commitments to other programs, this proposal documents that from 10/1990 until 12/31/1993 716 eligible patients from MSKCC entered clinical studies supported by the Phase II/III contract, an average of 220 per year. During the period 1/1/1993 to 12/31/1993, 1333 patients were treated on MSKCC IRB approved Phase II/III clinical trials. We also demonstrate our ability to confirm the dose and schedule selected for new agents having completed Phase I trials and beginning early Phase II studies, and our ability to select new agents in a variety of cancers. We have great experience in determining the anti-tumor activity of existing agents at significantly higher than usual doses using colony-stimulating factors or other agents to ameliorate dose limiting toxicity. We also have long experience in defining pharmacokinetic and pharmodynamic correlates to optimize individual dosing and explore other endpoints such as impaired and organ function or heavy prior treatment. Importantly, ancillary basic laboratory studies are an integral part of many of our trials as are quality of life assessments. In addition, we have the ability, when appropriate, to evaluate the costs of selected Phase II trials. The team directing this research has a national and international recognition for its efforts in drug development in the treatment of patients with malignancy.
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