9 AMINOCAMPTOTHECIN IN SOLID TUMORS

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This is a multicenter, open label, multiple dose, non-placebo controlled Phase I/II study. There are three parts of the study, Phase I, Phase IIA, and Phase IIB. The purpose of the Phase I part is to determine a dose to be used in the Phase II part. Patients with nonsmall cell lung, colorectal, pancreatic, gastric, bladder, prostate, head and neck cancers or renal cell are eligible for entry in Phase I. An estimated 9 patients, three patients in each of 3 groups or dose escalations of 9-AC, will be accrued based on consecutive order of enrollment (not cancer type) to confirm the maximum tolerated dose and dose limiting toxicities, should they occur at the levels studied. A dose of 9-AC to be used inthe Phase IIA part will be chosen based on the safety results from Phase I. The purpose of Phase IIA is to determine a tumor category to be used in Phase IIB. In Phase IIA, at least 14 evaluable patients will be enrolled for each of the 8 specific tumor types listed above for a total of 112 patients. Patients in the Phase I part who were at the chosen dose level or higher will be included in the group of 14 patients for their particular tumor type.