CALGB 60301: SORAFENIB FOR SOLID TUMORS AND HEMATOLOGIC MALIGNANCIES

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Sorafenib or BAY 43-9006 is a new oral anti cancer drug which inhibits the RAF kinase. This agent has activity against renal cancer and may also have anti tumor activity in colorectal cancer, melanoma, thyroid and pancreatic cancer. The safety of this new agent and its clearance has not been evaluated in patients with liver or renal dysfunction. In this phase I trial, patients with liver or kidney dysfunction (also a small cohort of patients with normal liver and renal function) will receive daily oral BAY 43-9006. If a cohort of three patients has no toxicity, the dose will be escalated in the next three patients until toxicity is observed and then a total of six patients would be entered at that dose. If more than one patient has a dose limiting toxicity that will be above the maximally tolerated dose (MTD) and the dose just below that will be considered the MTD for that degree of liver or renal dysfunction. Patients with varying degrees of liver or renal dysfunction, but not both, will be evaluated in separate cohorts.