Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer

OBJECTIVES:

• Determine the median, one-year, and long-term (defined as two-year) disease-free survival and overall survival in patients with previously irradiated locally recurrent squamous cell cancer of the head and neck treated with paclitaxel, cisplatin, and filgrastim (G-CSF) combined with radiotherapy.
• Determine the rates of acute and late toxic effects of this regimen in these patients.
• Determine the pattern of disease progression in patients treated with this regimen.

OUTLINE: Patients undergo radiotherapy twice daily (4-6 hours apart) on days 1-5. Patients receive paclitaxel IV over 1 hour beginning immediately after completion of the first fraction of radiotherapy and completing less than 3 hours before starting the second fraction of radiotherapy on days 1-5. Patients receive cisplatin IV over 30 minutes beginning immediately after completion of paclitaxel infusion on days 1-5 and filgrastim (G-CSF) subcutaneously on days 6-13. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who initially respond to therapy but develop a recurrence with a resectable lesion (inside or outside the retreatment field) may undergo surgical resection.

Patients are followed at 4 weeks after completion of radiotherapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 34 months.

DISEASE CHARACTERISTICS:

• Histologically proven locally recurrent primary squamous cell cancer (SCC) of the head and neck or second primary SCC of the head and neck

• More than 1 prior recurrence allowed if the first recurrence occurred at least 6 months after completion of prior radiotherapy
• Disease must be confined to the head and neck (above the clavicles)
• No primary SCC of the nasopharynx or salivary gland
• Prior irradiation of 45-75 Gy to the majority (75% or greater) of tumor volume
• Entire tumor volume must be included in a treatment field that limits the total spinal cord dose (prior and anticipated) to 50 Gy

• Prior radiotherapy records, including simulation and portal films, available in order to assure that cord tolerance is not exceeded
• Measurable disease
• Ineligible for complete surgical resection
• No distant metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0 or 1

Life expectancy:

• No other concurrent illness that would limit survival

Hematopoietic:

• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) no greater than 2 times normal*
• Alkaline phosphatase no greater than 2 times normal*
• * Greater than 2 times normal allowed if no metastases by liver ultrasound or CT scan

Renal:

• Creatinine no greater than 1.5 mg/dL

Other:

• No other invasive malignancy within the past 2 years except in situ malignancies (e.g., carcinoma in situ of the cervix, carcinoma in situ of the breast, or nonmelanoma skin cancer)
• No other concurrent illness that would impair tolerance to therapy
• No grade 2 or worse pre-existing peripheral sensory neuropathy
• No hypersensitivity to E. coli derived products
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior chemotherapy allowed as a component of the primary treatment
• No prior chemotherapy for recurrent disease
• At least 6 months since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 6 months since prior radiotherapy

Surgery:

• See Disease Characteristics