Docetaxel in Squamous Cell Carcinoma of the Head and Neck (TAX + Cisplatin in SCCHN)

Inclusion Criteria

• •Histologically confirmed (of original primary tumor) locoregional recurrent and/or metastatic following prior radiotherapy and/or surgery and not amenable to further curative local therapy for SCCHN
• •Measurable disease as defined by at least the longest diameter measured as 20 mm by conventional CT or 10 mm by spiral CT. Physical measurements are allowed if longest diameter is 20 mm by caliper measurements.
• •ECOG performance status 0-2
• •Adequate bone marrow and hepatic function as evidenced by the following:
• •* Hematology (Bone marrow):
• •* Neutrophils ≥ 1.50 x 10\^9/L
• •* Platelets ≥ 100 x 10\^9/L
• •* Hemoglobin ≥ 10 g/dL
• •* Hepatic function:
• •* AST and/or ALT: \< 2X ULN (Upper Limit of Normal)
• •* Bilirubin \< 1X ULN
• •Adequate renal function with calculated or measured glomerular filtration rate of \> 60 ml/min calculated by the Cockcroft- Gault method
• •No severe intercurrent illness or other serious illness or medical conditions including but not limited to:
• •* Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.
• •* Active uncontrolled infection
• •* Active peptic ulcer
• •* Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry
• •No prior chemotherapy for recurrent/advanced SCCHN with platinum or taxane regimen (primary radiosensitizing platinum allowed).
• •No other diagnosed malignancy other than basal cell carcinoma of the skin or cervix carcinoma in situ