| Inclusion Criteria: | 1) Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
2) Patients should have stage III or IV disease, staged T3-4 and/or N2-3, M0
3) Patients must have a Karnofsky performance status of >= 70
4) Age >/= 18 years
5) No hematogenous metastatic disease
6) Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 1500 cells/mm**3 and platelet count of > 100,000 cells/mm**3; adequate hepatic function with total bilirubin <= ULN, SGOT and SGPT may be up to 2.5 times the upper limit of normal if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4x ULN if SGPT and SGOT are normal. Patients who have SGPT > 1.5 ULN and alkaline phosphatase > 2.5 x ULN are not eligible.
7) Creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) x (wt. as kg)/serum Cr x 72 CrCl female = 0.85 x (CrCl male)
8) Patients must not have received previous surgery, other than diagnostic biopsy, or radiation, for this cancer. Patients may have received neoadjuvant chemotherapy which must have been completed > 3 weeks from beginning therapy on this trial.
9) Patients with a history of non-melanoma skin cancer, or other previous malignancies treated 5 years or more prior to the current tumor from which the patient has remained continually disease-free, are eligible.
10) Patients must sign a study-specific informed consent form.
11) Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 6 months thereafter. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy. |