Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically\* or cytologically\* confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic variants:
• •* Spindle cell carcinoma
• •* Poorly differentiated keratin-positive carcinoma
• •* Lymphoepithelioma NOTE: \*Biopsy or primary tumor and/or fine needle aspiration of the metastatic lymph node required
• •Original or second primary tumor
• •* Recurrent neck metastases with unknown primary allowed
• •Locally recurrent disease
• •Measurable disease
• •Unresectable disease
• •* Attempted surgical resection allowed provided surgery was performed ≥ 3 months ago, wound is completely healed, and there is no sign of carotid exposure
• •Must have had prior radiotherapy for SCC of the head and neck with \> 75% of the present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy
• •* Able to successfully re-irradiate the area of the gross tumor volume without exceeding lifetime spinal cord dose of 54 Gy as determined by physical examination and CT scan and/or MRI performed within the past 8 weeks
• •* First recurrence occurred \> 6 months after completion of radiotherapy
• •* More than 1 recurrence allowed provided the above criteria for first recurrence has been met
• •No primary tumor of the nasopharynx or salivary gland
• •No distant metastases by history or physical examination, chest CT scan, and CT scan or MRI of the tumor site
• •* Patients with equivocal pulmonary nodules are eligible provided the nodules are \< 1 cm, can be safely biopsied, or are negative by positron emission tomography imaging
• •* No circumferential tumor involvement of the carotid sheath by imaging unless prophylactic carotid stent is placed
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •Zubrod 0-1
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Absolute neutrophil count ≥ 1,800/mm³
• •Platelet count ≥ 100,000/mm³
• •Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
• •Hepatic
• •AST or ALT \< 2 times upper limit of normal (ULN)
• •Bilirubin \< 1.5 mg/dL
• •No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• •Renal
• •Creatinine clearance \> 50 mL/min
• •Calcium \< 11.5 mg/dL
• •Cardiovascular
• •No New York Heart Association class III or IV heart disease
• •No other symptomatic or uncontrolled cardiac disease
• •Pulmonary
• •No chronic obstructive pulmonary disease exacerbation
• •No other respiratory illness requiring hospitalization within the past 6 months or that would preclude study therapy
• •Immunologic
• •No AIDS
• •No prior allergic reaction to E. coli-derived products
• •No acute bacterial or fungal infection requiring IV antibiotics
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 30 days after completion of study treatment
• •No other invasive malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the breast, oral cavity, or cervix
• •No pre-existing peripheral sensory neuropathy \> grade 2
• •No other severe active co-morbidity
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •At least 6 months since prior chemotherapy
• •No prior systemic chemotherapy for recurrent SCC of the head and neck
• •* Prior neoadjuvant, adjuvant, and/or concurrent chemotherapy and radiotherapy for initial SCC of the head and neck allowed
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •See Disease Characteristics
• •See Chemotherapy
• •At least 6 months since prior radiotherapy
• •Surgery
• •See Disease Characteristics
• •Other
• •Prior cyclooxygenase-2 inhibitor or retinoids for chemoprevention allowed
• •At least 6 months since prior epidermal growth factor receptor (EGFR) inhibitors or other targeted agents
• •No prior EGFR inhibitors or other targeted agents for recurrent SCC of the head and neck
• •No concurrent cimetidine or allopurinol (for patients on arm II, regimen 1)