First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients

Inclusion Criteria:

• Recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx,hypopharynx, larynx or neck node with occult primary but suspected to benon-cutaneous head/neck that is incurable by local therapies (i.e. radiation orsurgery) and either locoregionally advanced or with at least one distant metastasis.

• Histologic or cytologic confirmation of malignancy by pathology report.

• Not a candidate for infusional 5FU (mucositis, 5-day infusional pump not feasible,patient refusal, other).

• 18 years old or greater.

• ECOG performance status of 0-2.

• Life expectancy of greater than 3 months.

• Patients must have normal organ and marrow function as defined: Absolute neutrophilcount greater than or equal to 1,000/mcL, platelets greater than or equal to 75,000/mcL, total bilirubin less than or equal to 2 mg/dL

• Ability to understand and the willingness to sign an IRB-approved informed consentdocument (either directly or via a legally authorized representative).

Exclusion Criteria:

• No prior systemic cancer-directed therapy administered in the recurrent ormetastatic setting. Prior treatments are allowed if they were administered withcurative intent prior to incurable progression of disease. Prior treatments forother cancers are also allowed.

• Untreated, symptomatic central nervous system (CNS) metastases.

• Active autoimmune disease requiring systemic immunosuppression.

• History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalentprednisone >20 mg/day for >1 week).

• History of greater than or equal to Grade 3 hypersensitivity reaction to carboplatinor paclitaxel.

• Uncontrolled intercurrent illness including, but not limited to ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.

• Pregnant women are excluded from this study because paclitaxel and carboplatin areClass D agents with significant potential for teratogenic or abortifacient effects.Because there is an unknown but potential risk for adverse events in nursing infantssecondary to treatment of the mother with these drugs, breastfeeding should bediscontinued during the study.