OBJECTIVES:

• Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy.
• Determine the toxicity of this treatment regimen in this patient population.
• Determine the efficacy of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of docetaxel.

Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy alone twice daily for 2 weeks.

Upon completion of chemoradiotherapy, patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy.

Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. Additional patients are treated at the MTD.

Patients are followed monthly for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) or its variants (e.g., lymphoepithelioma or undifferentiated epidermoid carcinoma)

  • Stage III or IV (M0) disease

• Must have had prior platinum/fluorouracil based initial induction chemotherapy (may have included a taxane)

  • Previously untreated disease prior to induction regimen
  • Received 1-3 courses of chemotherapy and less than 7 weeks from the beginning of the last course of induction therapy
  • Evaluable disease during induction therapy required
• No prior head and neck carcinoma except if treated with surgery as sole modality at least 2 years prior to study

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Greater than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3 OR
• Absolute neutrophil count at least 1,000/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

• SGOT less than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase less than 2.5 times ULN
• Bilirubin normal
• SGOT no greater than 2 times ULN

Renal:

• Not specified

Cardiovascular:

• No acute cardiac dysrhythmias or unstable cardiac condition (e.g., angina)

Other:

• No other concurrent malignancy within the past 3 years except curatively treated limited basal or squamous cell skin cancer or carcinoma in situ of the cervix
• Adequate and nutritionally balanced enteral intake (at least 1,800 kcal/day)
• No persistent diarrhea
• No peripheral neuropathy of any etiology greater than grade 2
• No other serious illness or medical condition
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• At least 5 years since any other form of prior chemotherapy

Endocrine therapy:

• Prior hormonal therapy allowed

Radiotherapy:

• No prior radiotherapy for SCCHN

Surgery:

• See Disease Characteristics
• Percutaneous endoscopic gastrostomy required prior to radiotherapy

Other:

• No IV alimentation as primary source of calories
• Completely recovered from prior diagnostic or therapeutic procedures