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Tarceva for head and neck cancer

Posted Nov 25 2009 10:03pm

Tarceva is currently FDA approved for pancreatic cancer in combination with gemcitabine and for non-small cell lung cancer for second line. There are ongogn trials in head and neck cancer, for example, Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA), NCT00304278. The purpose of this study is to determine the safety and effectiveness of treatment with Tarceva (Erlotinib) and RADPLAT (RADiation and intraaterial cisPLATin) for patients with Head and Neck cancer. There is also: A Study of Tarceva (Erlotinib) in Patients With Resected Head and Neck Squamous Cell Cancer.
This study is currently recruiting participants, NCT00412217. This 2 arm study will compare the efficacy and safety of Tarceva, versus standard of care, in patients with resected head and neck squamous cell cancer who are receiving concurrent chemo-radiotherapy or radiotherapy alone. Patients will be randomized to receive either Tarceva 150mg po daily or standard of care. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. According to the results of a Phase I/II clinical trial, treatment of recurrent or metastatic squamous cell cancer of the head or neck with a combination of two targeted therapies-Avastin® (bevacizumab) and Tarceva® (erlotinib), not Tarceva alone -was well tolerated and provided a benefit to some patients. There is also a phase II trial, that suggests that Tarceva as a single agent prolongs survival in patients with refractory squamous cell cancer of the head and neck.
Hidalgo M. Phase I studies/combination therapy with Tarceva (erlotinib HCL;OSI-774) in head and neck cancer. Presented at: The First Annual Opinion Leader Consortium on Novel and Targeted Therapies for Head and Neck cancer. San Juan, Puerto Rico:. February 5-9, 2003.
Cohen EEW, Davis DW, Karrison TG et al. Erlotinib and bevacizumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck: a phase I/II study. Lancet Oncology. 2009;10:247-57.
Hidalgo M, Siu LL, Nemunitis J, Rizzo J, Hammond LA, Takimoto C, et al. Phase I and Pharmacologic Study of OSI-774, an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, in Patients With Advanced Solid Malignancies. J Clin Oncol 2001; 19:3267-79

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