PHASE II/III CLINICAL TRIALS OF ANTICANCER AGENTS

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The objectives of this contract are: 1) when testing new agents which have just completed Phase I trials, to confirm that the dose and schedule chosen can be safely given in subsequent Phase II trials; 2) to determine the antitumor activity of existing antitumor agents which can administered in significantly higher doses when used with colony stimulating factors or other factors which modulate toxicity or antitumor activity; 3) to determine the antitumor activity of combinations of antitumor agents and modalities; 4) to evaluate the laboratory parameters which may correlate with or predict for response; and 5) to determine the spectrum of antitumor activity for new agents in selected human cancers. While the contract will permit occasional Phase III trials, the major emphasis shall be on the early Phase II studies which are pivotal for drug development and require rapid initiation, completion and data reporting.