Phase II trial of the EGFR tyrosine kinase inhibitor erlotinib for single agent therapy of recurrent Glioblastoma Multiforme: Interim results

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1558 Background: Erlotinib (Tarceva, OSI-774) is an orally available small molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. We have initiated the first phase II trial of erlotinib in single agent therapy of recurrent glioblastoma multiforme (GBM). Methods: Patients with documented recurrent or progressive GBM who have received previous radiation therapy and cytotoxic chemotherapy were eligible for enrollment. No enzyme-inducing anti-epileptic agents were allowed. Patients were treated with 150 mg of erlotinib per day until tumor progression or study withdrawal. Tumor response was determined by MRI. Analysis for EGFR amplification was performed. Results: Interim analysis has been performed on a total of 16 of 31 planned patients as of December, 2003. Of these, 4 patients have shown partial responses, 1 showed a partial response of his original tumor but then developed a separate unresponsive focus and 4 have had disease stabilization for greater than 3 months. Seven patients have...