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

Inclusion Criteria

• •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)