Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma

Pts must have histolgically or cytol confirmed malignant high-grade salivary gland ca of the H&N (except adenoid cystic carcinoma) that is either met or recurrent and is not amenable to salvage srg resection or RT. Elig histologies are adenocarcinoma, acinic cell carcinoma, mucoepidermoid carcinoma, salivary duct and undiffereniated carcinoma. Pts must have tumors that carry HER-2 gene amplification as determined by 1) FISH or, 2) overexpression of HER-2 protein, 2+ to 3+ level assessed by IHC. Pts must have measurable dz (assessed w/i 28 days prior to reg) or non-measurable dz (assessed w/i 42 days prior to reg). Pts w/ known brain mets are not elig. Pts must have and must be willing to submit tumor tissue for path review & translational medicine studies & pts must be offered opportunity to participate in specimen banking for future research. Pts previously tx w/ chemo are elig provided at least 28 days have elapsed since last course was completed & pt has recovered from toxicities. Prior RT and srg must have been completed w/in 28 days prior to reg and all toxicities and surgical events resolved. Pts must not be planning on receiving any other investigational agent, other chemo, RT, or hormonal tx while receiving protocol tx (except for steriods admin for antimesis, adrenal failure or septic shock or hormones admin for non-dz related conditions). PS 0-2. Pts must have adequate hematologic, hepatic, and renal function (as defined in the protocol). Pts w/ known h/o allergic react to compounds of similar chemical or biologic composition to trastuzumab are not elig. Must not be pregnant or nursing. Pts of reproductive potential must agreed to use effective contraceptive method. Pts must be 18 y/o.