Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed squamous cell carcinoma of the head and neck
• •Metastatic, persistent, or recurrent disease
• •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• •Must have had definitive surgery and/or radiation therapy AND received at least 1, but no more than 2, chemotherapy regimens, either given as primary therapy or adjuvant therapy before or after surgery and/or radiotherapy
• •No active or prior CNS metastasis
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •SWOG 0-2
• •Life expectancy
• •At least 12 weeks
• •Hematopoietic
• •Granulocyte count \> 1,500/mm\^3
• •Hemoglobin ≥ 8 g/dL
• •Platelet count \> 100,000/mm\^3
• •Hepatic
• •Bilirubin normal
• •Meets 1 of the following criteria:
• •* Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
• •* AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
• •* AP ≤ 5 times ULN AND AST or ALT normal
• •Renal
• •Creatinine \< 1.5 mg/dL
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• •No peripheral neuropathy ≥ grade 2
• •No active infection requiring systemic therapy
• •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or any other site
• •No history of severe hypersensitivity reaction to study drugs or other drugs formulated with polysorbate 80
• •No other serious condition that would preclude study treatment
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •See Disease Characteristics
• •No prior taxane or gemcitabine
• •At least 4 weeks since prior chemotherapy and recovered
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy and recovered
• •Surgery
• •See Disease Characteristics
• •Other
• •No other concurrent therapy for this disease