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.
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