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

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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.