• Feasibility of treatment [ Designated as safety issue: No ]
  

• Disease-free interval and failure sites [ Designated as safety issue: No ]
  
• Correlation of molecular markers with treatment outcome [ Designated as safety issue: No ]
  
• Correlation of quality of life with treatment outcome [ Designated as safety issue: No ]
  
• Frequency and severity of toxicities [ Designated as safety issue: Yes ]
  
• Treatment completion [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the feasibility of a new intensification regimen comprising cisplatin and paclitaxel in combination with radiotherapy and surgery in patients with resectable advanced squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx.

Secondary

• Assess the disease-free interval and failure sites in patients treated with this regimen.
• Correlate molecular markers with treatment outcome in these patients.
• Correlate quality of life with treatment outcome in these patients.
• Determine the frequency and severity of toxicities of this regimen in these patients.
• Evaluate treatment completion in these patients.

OUTLINE:

• Preoperative therapy (weeks 1 and 2): Patients receive cisplatin IV over 2 hours on days 1-3. Patients also undergo intensity-modulated external beam radiotherapy once daily on days 1-5 and 8-12.
• Surgery (week 3): Patients undergo surgical resection of the primary tumor (with or without neck dissection) and intraoperative boost radiotherapy.
• Postoperative therapy (weeks 7-10): Patients receive cisplatin IV over 2 hours on days 1-3 and 22-24 and paclitaxel IV over 3 hours on days 1, 8, 15, and 22. Patients also undergo intensity-modulated external beam radiotherapy on days 1-5, 8-12, 15-19, and 22-26.

Patients undergo blood and tissue sample collection at baseline, in weeks 3, 7-10, and 14, and then periodically thereafter for biomarker correlative studies.

Quality of life is assessed at baseline, at 3, 6, and 12 months after completion of treatment, and then annually thereafter.

After completion of study treatment, patients are followed every 2 months for 1 year and then periodically thereafter.

DISEASE CHARACTERISTICS:

• Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx

  • Stage III, IVA, or IVB (without distant metastases) disease

    • Stage II hypopharyngeal carcinoma allowed
• Resectable disease
• No distant metastases

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Life expectancy ≥ 6 months
• Platelet count ≥ 100,000/mm³
• ANC ≥ 2,000/mm³
• Bilirubin normal
• AST and ALT < 4 times upper limit of normal
• Creatinine normal OR creatinine clearance > 60 mL/min
• Not pregnant or nursing
• Negative serum pregnancy test
• Fertile patients must use effective contraception
• Prior bradyarrhythmias, AV conduction defects, or marginal cardiac function allowed
• No prior demyelinating neurological disorder, such as multiple sclerosis
• No prior pancytopenia or aplastic anemia
• No other prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
• No condition that would be considered a contraindication for fluid challenge

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy (to the primary site or nodes)
• No concurrent immunotherapy or hormonal therapy, except oral contraceptives or hormone replacement therapy