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

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。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。本研究将分两个连续部分进行，即A部分和B部分。在A部分和B部分中，患者将在开始同步放化疗前的14天诱导“窗口”期间接受每日口服OSI-774单药治疗。A部分将是在患有口咽（OP）和口腔（OC）的II期（T2 NO）或III期（T1- 2N 1）鳞状细胞癌的患者（A组）中每日口服OSI-774与标准分次外部射束放射疗法组合的最大耐受剂量（MTD）的I期剂量探索研究。在A部分确定OSI-774和标准分次外射束放射治疗的第一个剂量水平的安全性后，B部分将开始招募该剂量水平的患者。B部分将是一项在III期（T3 N 0 -1）或IV期（T1- 4 N2 - 3 M0，T4 N 0 M0）OP和OC鳞状细胞癌患者（B组）中进行的每日口服OSI-774低剂量每日顺铂化疗（6 mg/m2/天）联合同步标准分割外射束放疗的I期剂量探索研究。患者将继续每日口服OSI-774，直至出现不可接受的毒性或疾病进展，最长持续两年。

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.