Clinical Trials

Inclusion Criteria:

• Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
• Patients should have selected Stage III or IV disease (T2N2-3M0, T3-4 any N M0)
• Patients must have Zubrod Performance Status of 0-1.
• Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
• Age ≥  18 years of age.
• 1.  
• Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of:
  • > 2000 cells/mm^3;
  • platelet count of > 100,000 cells/mm^3;
  • adequate hepatic function with bilirubin < 1.5 mg/dl;
  • AST or ALT < 2 x the upper limit of normal;
  • serum creatinine < 1.5 mg/dl, creatinine clearance > 50 ml/min;
  • normal serum calcium (or normal corrected serum calcium).
  • Formula for corrected calcium if albumin value is below normal range:
  • Corrected calcium (mg/dl) = [ 4 – [patient albumin (g/dl)] x 0.8 + patient calcium (mg/dl);
• Creatinine clearance (CC) > 50 ml/min is determined by 24 hour collection or nomogram: 
  • CC male = (140 - age) x (wt. in kg)
    • Serum Cr mg/dl) x 72
  • CC female = 0.85 x (CC male)
• No symptomatic coronary artery disease (angina) or history of myocardial infarction within the last 6 months; patients with symptomatic angina who are subsequently determined to be disease free are eligible.
• Patients with a history of non-melanoma skin cancer, or other previous invasive malignancies from which the patient has remained continually disease free for > 3 years.

Exclusion Criteria:

• 1.  
• Histology other than squamous cell carcinoma.
• Patients with T1-2N1 or T1N2-3.
• Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
• Prior chemotherapy for any reason or prior radiotherapy to the head and neck region except for radioactive iodine therapy.
• Initial surgical treatment excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted.
• Patients with simultaneous primaries.
• Pregnant women because of the embryotoxic effects of chemotherapy.