Trastuzumab in Treating Patients With Advanced Salivary Gland Cancer

Inclusion Criteria

• •Histologic diagnosis of any of the following malignancies originating from salivary tissue: adenoid cystic carcinoma, mucoepidermoid carcinoma, acinic cell carcinoma, malignant mixed tumor, polymorphous low grade adenocarcinoma, undifferentiated carcinoma, squamous cell carcinoma, adenocarcinoma.
• •Her2/neu determination: Patients must have overexpression of the Her2/neu protein in the tumor documented by the Dako polyclonal rabbit anti-Her2 antisera assay.
• •Overexpression may be documented by staining of the original paraffin embedded tumor from the time of diagnosis or from material obtained at the time of locoregional or distant recurrence.
• •Overexpression of HER2/neu will be per the Dako Herceptest guidelines. A Score of 2+ or 3+ will be defined as overexpression. All slides will be reviewed by members of the departments of pathology at either the Brigham and Women's Hospital or the Beth Israel Hospital in Boston.
• •Patients must be incurable on the basis of unresectable local or distant disease as determined by the patient's surgeon.
• •Patients must have an ECOG performance status of 0 to 1.
• •Patients must have at least uni-dimensionally measurable disease documented within one month of initiation of treatment. Measurement may be by physical exam or radiologically. Attempts should be made to photo document all tumor sites assessed by physical examination with a metric ruler within the photo for measurement confirmation.
• •Patients must be willing and able to go through the process of informed consent.
• •Patients must have a life expectancy exceeding 3 months.
• •Patients must be at least 18 years old.
• •Patients must have adequate organ function as defined by the following tests to be performed within 14 days of therapy initiation:
• •* Absolute neutrophil count \> 1999 cells x 10 61L
• •* Platelet count \> 99,999 cells x 106/L
• •* Hemoglobin \>8.5 gm/di or HCT \> 25%
• •* Serum creatinine \< 1.5 x institutional upper limits of normal (ULN) or creatinine clearance measured by 24 hour urine collection as at least 50% of institutional lower limit of normal.
• •* Total bilirubin \<2 x institutional ULN
• •* AST (SGOT) \< 2 x institutional ULN \*
• •If from documented liver involvement with cancer, may be up to \< 5 x institutional ULN Alkaline Phosphatase \< 5 x institutional ULN \*
• •If from documented bone or liver involvement with cancer, no upper limit restriction.
• •Baseline determination of normal left ventricular ejection fraction as evidenced MUGA or echocardiogram.