Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
• * Recurrent or metastatic disease
• Measurable disease
• Not a candidate for curative therapy
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,500/mm³
• Hemoglobin ≥ 8.0 g/dL
• Platelet count ≥ 100,000/mm³
• AST, ALT, and alkaline phosphatase (AP) meeting 1 of the following criteria:
• * AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
• * AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
• * AP ≤ 5 times ULN AND AST and ALT normal
• Bilirubin normal
• Creatinine clearance ≤ 2.0 mg/dL
• No peripheral neuropathy ≥ grade 2 within the past 28 days
• No myocardial infarction within the past 6 months
• No New York Heart Association class III or IV heart failure
• No uncontrolled angina
• No severe uncontrolled ventricular arrhythmias
• No electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• No known hypersensitivity to bortezomib, boron, or mannitol
• No known severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
• No serious medical or psychiatric illness that would preclude study participation
• No other malignancy within the past 3 years except for early-stage nonmelanomatous skin cancer, carcinoma in situ of the cervix, or early-stage prostate cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• PRIOR CONCURRENT THERAPY:
• No prior chemotherapy for recurrent or metastatic disease
• At least 28 days since prior and no other concurrent investigational drugs
• No other concurrent anticancer therapy
• No other concurrent chemotherapy
• No concurrent complementary or herbal medicine
• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)