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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 目的： 本研究的主要目的是确定索拉非尼联合顺铂/依托泊苷和卡铂/培美曲塞的推荐二期剂量(RP2D)和耐受量。次要目标是确定索拉非尼联合应用的毒性。 根据RECIST标准或适用的肿瘤标志物(如前列腺特异性抗原(PSA)、CA-125等)评估疗效；并确定索拉非尼和依托泊苷联合应用时的药代动力学。 参与者： 参与者将是被组织学或细胞学诊断为转移性实体肿瘤的患者，他们至少在一种标准治疗上取得了进展，或者患有一种没有标准治疗的疾病。 程序(方法)： 这是一项双臂I期试验，每只手臂采用3+3设计。剂量升级和降级将基于在第一个周期中观察到的毒性。毒性将使用国家癌症研究所(NCI)共同毒性标准不良事件(CTCAE)3.0版进行评估。登记、毒性评估和剂量递增将在每个手臂上独立，并且不会尝试比较这两个治疗手臂。两个ARM研究设计将提供两种不同治疗的毒性信息，交替登记允许更快速的收益，因为当在ARM A上收集毒性数据时，患者可以继续在ARM B上登记。参与者将根据分配的ARM在21天周期内接受治疗，直到患病 进展、不可接受的毒性或调查员的自由裁量权。

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.