LCCC 0509: A TWO-ARM PHASE I DOSE ESCALATION TRIAL OF VINFLUNINE

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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. This is an open label, non-randomized phase I dose escalation trial in refractory solid tumors. Patients will be enrolled to one of two arms, vinflunine/erlotinib or vinflunine/pemetrexed, to define the maximum tolerated doses (MTD) of each combination. We will also investigate whether vinflunine is a CYP3A4 substrate, and if CYP3A4 activity predicts vinflunine clearance with the use of a midazolam CYP3A4 probe.