COMBINATION OF WEEKLY CHEST RADIOTHERAPY AND ORAL NAVELBINE FOR NSCLC

每周胸部放射治疗和口服长春花碱相结合治疗非小细胞肺癌

• 批准号: 7376271
• 负责人: PAUL O SCHWARZENBERGER
• 金额: $ 0.37万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376271
• 关键词: COMBINATION; WEEKLY; CHEST; RADIOTHERAPY; ORAL

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 a voluntary experimental trial intended for subjects who have been diagnosed with non-small cell lung cancer. The subject may have received prior chemotherapy treatment for this disease; however, prior radiotherapy to the chest will exclude the subject from participation. Although not all tissue types of lung cancer are eligible to participate in this study, the majority of lung cancers (approximately 80%) are of the particular type sought for this study. The study is designed for subjects whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. Subjects at this stage of their disease traditionally receive radiation therapy or chemotherapy or both treatments in succession. Recently, the administration of both methods of treatment concurrently has been employed and indicates somewhat better results. Specifically, a class of chemotherapy agents called Vinca Alakaloids used in combination with radiation therapy appears promising as determined in small studies. The drug Navelbine is part of this class of drugs. This drug is given as an infusion through the veins, its pill form is currently under development. The administration via pill would be easier and avoid previously experienced side effects that were experienced by infusion into the veins of subjects. Nevertheless, the best treatment for lung cancer has not been established yet and additional studies are necessary to find better ways of treating lung cancer have not been established yet and additional studies are necessary to find better ways of treating lung cancer. One goal of this study is to investigate how much of the Navelbine tablet can be given together with radiation and will result in enhanced shrinkage of the cancer. In this study the radiation will be given one day per week, rather than divided over five days per week as is more commonly used. However, in various studies worldwide, once weekly chest irradiation by itself has been found to be at least as good as the more commonly used daily radiotherapy. The proposed study will use increasing doses of the drug Navelbine in pill form to find the highest dose of Navelbine that is tolerated in conjunction with radiation therapy. Initially, each subject will receive one dose of Navelbine, which is higher than the does of the previous subject. This escalation will continue until the highest tolerated dose has been determined. Then, subjects enrolled subsequently into the study will receive a lower, and previously determined to be well-tolerated dose of Navelbine, which will be combined with a drug called Cisplatin. Cisplatin is a standard medicine for lung cancer and will be administered via infusion into the vein of the subject at a low dose. A total of 15 patients will then be treated with this combination of drugs together with once weekly radiation. The overall purpose of this study is to evaluate if the chemotherapy drug combination of Navelbine and Cisplatin administered once weekly with radiation given on one day is an effective therapy for non-small cell lung cnacer. This trial will also investigate how well this treatment is tolerated and what effects this treatment will have on the everyday life and activities of participants.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这是一项针对被诊断为非小细胞肺癌的受试者的自愿性实验试验。该受试者可能已经接受了这种疾病的化学疗法治疗。但是，先前对胸部的放疗将排除受试者的参与。尽管并非所有组织类型的肺癌类型都有资格参加这项研究，但大多数肺癌（约80％）都是为此研究所寻求的。该研究是为癌症过于先进的受试者而设计的，因此无法以完全消除癌症的目的进行操作。传统上，受试者在其疾病的这个阶段接受放射疗法或化疗或两种疗法连续接受。最近，同时采用了两种治疗方法的给药，并表明结果更好。具体而言，一类称为Vinca alakaloids与放射疗法结合使用的化学疗法剂似乎有望在小型研究中确定。药物午睡是这类药物的一部分。该药物是通过静脉注入的，目前正在开发其药丸形式。通过药丸给药会更容易，并且避免了先前经历的副作用，这些副作用是通过输注到受试者静脉的情况下经历的。然而，尚未确定对肺癌的最佳治疗方法，以找到更好的治疗肺癌的方法需要进一步的研究，并且还没有建立其他研究，而对于找到更好的治疗肺癌的方法是必要的。这项研究的一个目标是研究可以与辐射一起给出多少肚脐片剂，并将导致癌症收缩的收缩增强。在这项研究中，辐射每周将进行一天，而不是每周五天分裂，因为更常用。但是，在全球各种研究中，已经发现，每周一次的胸部照射一次至少与更常用的日常放射疗法一样好。拟议的研究将以药丸形式增加剂量的药物鼻子剂量，以找到与放射治疗结合使用的最高剂量的鼻腔剂量。最初，每个受试者都会收到一剂的午睡，高于先前受试者的剂量。这种升级将持续到确定最高耐受剂量为止。然后，随后入学的受试者将接受较低的且先前确定的纳维尔丁剂量良好的剂量，该剂量将与称为顺铂的药物结合使用。顺铂是一种用于肺癌的标准药物，将通过低剂量通过输注对受试者的静脉进行施用。然后，将总共15例患者与每周辐射一起使用这种药物组合。 这项研究的总体目的是评估每周一次给药的肠鼻涕和顺铂的化学疗法药物组合是否是对非小细胞肺CNACER的有效疗法。该试验还将调查这种治疗方法的容忍度，以及这种治疗对参与者的日常生活和活动的影响。