CLINICAL TRIAL: CISPLATIN/ETOPOSIDE OR CARBOPLATIN/PEMETREXED IN PATIENTS WITH S

这个子项目是众多研究子项目之一

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. Purpose: The primary objective of this research is to determine the recommended phase two dose (RP2D) and tolerable dose of sorafenib in combination with cisplatin/etoposide and carboplatin/pemetrexed. Secondary objectives are to characterize the toxicities of sorafenib in combination with cisplatin/etoposide and carboplatin/pemetrexed; to evaluate for efficacy using the definition of best response by RECIST criteria or by tumor markers if applicable (i.e. prostate specific antigen (PSA), CA-125, etc); and to determine the pharmacokinetics of sorafenib and etoposide when administered in combination. Participants: Participants will be patients with histological or cytological diagnosis of metastatic solid tumors who have progressed on at least one standard therapy or who have a disease for which there is no standard therapy. Procedures (methods): This is a two arm phase I trial using the ¿??3+3¿?¿ design in each arm. Dose escalation and deescalation will be based on the toxicities observed during the first cycle. Toxicities will be evaluated using the National Cancer Institute (NCI) Common Toxicity Criteria Adverse Events (CTCAE) version 3.0. Enrollment, toxicity assessment, and dose escalation will be independent on each arm, and there will not be any attempt to compare the two treatment arms. The two arm study design will provide toxicity information on two different treatments, and the alternating enrollment allows for more rapid accrual since while toxicity data is being collected on arm A, patients can continued to be enrolled on arm B. Participants will receive treatment according to the assigned arm in 21 day cycles until disease progression, unacceptable toxicity, or investigator discretion.