STUDY OF OSI-774 IN COMBINATION WITH RADIATION THERAPY IN ORAL CAVITY CANCER

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究将分两部分进行，A部分和B部分。在A部分和B部分，患者将在同步放化疗开始前14天的诱导“窗口期”内每天接受单剂口服OSI-774。A部分将是一项I期剂量发现研究，目的是对II期(T2NO)或III期(T1-2N1)口咽鳞状细胞癌(OP)和口腔鳞状细胞癌(OC)患者进行每日口服OSI-774与标准分割外放射治疗相结合的最大耐受剂量(MTD)研究(A组)。在A部分确定了OSI-774的第一剂量水平和标准分割外放射治疗的安全性后，B部分将开始招募处于该剂量水平的患者。B部分将是一项I期剂量发现研究，即每日口服OSI-774低剂量顺铂化疗(每天6 mg/m2/天)和同时进行标准分割外照射治疗III期(T3N0-1)或IV期(T1-4N2-3M0，T4N0M0)OP和OC的鳞癌患者(B组)。患者将继续每天口服OSI-774，直到不可接受的毒性或疾病进展最多两年。

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 study will be conducted in two sequential parts, Part A and B. In both Parts A and B, patients will receive single agent daily oral OSI-774 during a fourteen day induction "window" prior to start of concurrent chemoradiation. Part A will be a phase I dose finding study to maximum tolerated dose (MTD) of daily oral OSI-774 in combination with standard fractionation external beam radiation therapy in patients with stage II (T2NO) or stage III (T1-2N1) squamous cell carcinoma of the oropharynx (OP) and oral cavity (OC) (Group A). After the safety of the first dose level of OSI-774 and standard fractionation external beam radiation therapy has been determined in Part A, Part B will begin to enroll patients at that dose level. Part B will be a phase I dose finding study of the combination of daily oral OSI-774 low dose daily cisplatin chemotherapy (6 mg/m2/day) and concurrent standard fractionation external beam radiation therapy in patients with stage III (T3N0-1) or IV (T1-4N2-3M0, T4N0M0) squamous cell carcinoma of the OP and OC (Group B). Patients will continue daily oral OSI-774 until unacceptable toxicity or disease progression for a maximum of two years.