Docetaxel With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
• Metastatic or locally recurrent disease
• No histologic type WHO 2 or 3 nasopharyngeal carcinoma
• Incurable by local therapies
• Meets 1 of the following criteria:
• ECOG 2 AND no prior chemotherapy for metastatic or locally recurrent head and neck cancer
• ECOG 0-2 AND received prior chemotherapy (i.e., ≥ 1 prior chemotherapy regimen [without docetaxel]) for metastatic or locally recurrent disease OR received prior chemotherapy (without docetaxel) as part of a primary curative therapy within the past 6 months
• Measurable or non-measurable disease
• Disease within a previously irradiated field is considered measurable provided there is unequivocal disease progression or biopsy-proven residual carcinoma after radiotherapy
• Persistent disease after radiotherapy must be biopsy-proven ≥ 8 weeks after completion of radiotherapy
• No tumors that are unequivocally invading major vessels (e.g. carotid artery)
• No tumor-related hemorrhagic events in the past 3 months that require major medical intervention (e.g., surgery or embolization)
• No known brain metastasis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• See Disease Characteristics

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 8.0 g/dL

Hepatic

• Alkaline phosphatase AND AST or ALT meeting criteria for 1 of the following:
• Alkaline phosphatase normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times UNL AND AST or ALT ≤ 1.5 times ULN
• Alkaline phosphatase ≤ 5 times ULN and AST or ALT normal
• Bilirubin normal
• Renal
• Creatinine < 2.0 mg/dL OR
• Creatinine clearance > 60 mL/min

Cardiovascular

• No uncontrolled hypertension
• No unstable angina
• No congestive heart failure
• No serious arrhythmia requiring medication

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• No hypercalcemia related to head and neck cancer
• No peripheral neuropathy ≥ grade 2
• No hypersensitivity to gefitinib or any of its excipients
• No severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
• No unstable systemic disease
• No active infection
• No significant traumatic injury within the past 3 weeks
• No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
• No other co-existing condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior monoclonal antibody ABX-EBX or monoclonal antibody MDX-447
• No prior cetuximab
• At least 2 weeks since prior biologic/targeted therapy
• No concurrent immunotherapy
• No concurrent colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

Chemotherapy

• See Disease Characteristics
• Prior paclitaxel allowed provided there was no disease progression during treatment
• At least 4 weeks since prior chemotherapy and recovered
• No prior docetaxel
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent antitumor hormonal therapy
• Concurrent contraceptives, replacement steroids, and dexamethasone allowed

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered
• No concurrent radiotherapy

Surgery

• At least 3 weeks since prior major surgery and recovered

Other

• See Disease Characteristics
• No other prior systemic epidermal growth factor receptor inhibitors, including any of the following:
• Gefitinib
• Erlotinib
• PKI166
• CI-1033
• EKB-569
• No concurrent CYP3A4 inducers, including any of the following:
• Phenytoin
• Carbamazepine
• Rifampin
• Phenobarbital
• Hypericum perforatum (St. John's wort)
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent proton pump inhibitors or H2 antagonists within 4 hours after gefitinib administration
• No concurrent therapeutic anticoagulation
• No other concurrent antitumor therapy
• No other concurrent experimental medications