Paclitaxel, Carboplatin and Radiotherapy as Induction Therapy in Locally Advanced Head and Neck Cancer

Inclusion Criteria

• Adult patients greater than 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
• Patients with pathologically documented bulky T2, III and IV squamous cell cancer of the head and neck (excluding M1 disease), within 2 months of diagnosis. Bulky T2 tumors are defined as those that have a volume of disease greater than 35 cm3 as measured by CT or MRI scan (26).
• Patients will be medically fit for undergoing chemotherapy. Specifically:
• no evidence of active angina pectoris or ventricular arrhythmias; no myocardial infarction within the last six months. (Patients with medically controlled hypertension or congestive heart failure are eligible.)
• an absolute neutrophil count of > 1000/uL and platelet count > 100,000/microliter (uL)
• serum total bilirubin < 1.5 mg/dL
• Creatinine Clearance greater than 50 ml/min

Using an actual or calculated creatinine clearance using the formula:

(140 - age) x (wgt in kg)*/(serum creatinine)x(72)*= multiply by 0.85 for females

• if a pre-existing grade I neuropathy exists, patients must be willing to risk worsening neuropathy secondary to Paclitaxel. Patients with grade II or greater neuropathy will be excluded from study.
• ability to give written, informed consent to participate in the trial.
• Patients will have measurable disease as determined by MRI or CT scan or evaluable disease determined by panendoscopy to be eligible for enrollment on this study.

Exclusion Criteria

• Pregnant females. Males and women of childbearing potential must use effective contraception in order to prevent pregnancy during therapy.
• Patients with a history of previous or current malignancy at other sites diagnosed within the last 5 years, with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain free of recurrence or metastases for greater than five years are eligible.
• Patients with active infection will not be eligible for this protocol until the infection is treated and the symptoms have clinically resolved.
• Patients with a history of allergy to drugs utilizing Cremophor in the formulation.
• Prior induction chemotherapy, prior irradiation or surgery will not be allowed.
• Patients with metastatic disease will not be eligible for this study.
• Patients with grade II or greater peripheral neuropathy will be excluded from study.