Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed non-small cell lung cancer
• •* Locally advanced (stage IIIB) or metastatic (stage IV) disease
• •* Inoperable disease
• •Relapsed or refractory disease
• •* Received 1, and only 1, prior chemotherapy regimen for locally advanced or metastatic disease
• •Measurable or evaluable disease
• •No symptomatic or inadequately treated brain metastases
• •No CNS disease
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •Karnofsky 70-100%
• •Life expectancy
• •More than 3 months
• •Hematopoietic
• •Platelet count greater than 100,000/mm\^3
• •Hemoglobin greater than 8.0 g/dL
• •Absolute neutrophil count greater than 1,500/mm\^3
• •Hepatic
• •AST and ALT less than 3 times upper limit of normal (ULN)
• •Bilirubin less than 1.5 times ULN
• •Hepatitis B surface antigen negative
• •Hepatitis C negative
• •Renal
• •Creatinine less than 1.8 mg/dL
• •Cardiovascular
• •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 poorly controlled hypertension
• •Immunologic
• •No active systemic infection requiring treatment
• •No prior allergic reaction attributable to compounds containing boron or mannitol
• •HIV negative
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective barrier contraception
• •No peripheral neuropathy grade 2 or greater
• •No diabetes mellitus
• •No other serious medical or psychiatric condition that would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •More than 6 weeks since prior monoclonal antibody therapy
• •No concurrent routine use of colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
• •No concurrent immunotherapy
• •Chemotherapy
• •See Disease Characteristics
• •More than 4 weeks since prior chemotherapy
• •No prior docetaxel
• •* Prior paclitaxel allowed
• •No other concurrent chemotherapy
• •Endocrine therapy
• •No concurrent corticosteroids (e.g., prednisone or prednisolone) except dexamethasone as premedication
• •Radiotherapy
• •More than 4 weeks since prior radiotherapy
• •No concurrent radiotherapy
• •Surgery
• •More than 4 weeks since prior major surgery
• •No concurrent surgery for cancer management or treatment
• •Other
• •More than 5 years since prior treatment for any other cancer except basal cell skin cancer or carcinoma in situ of the cervix
• •More than 4 weeks since prior investigational agents
• •No prior bortezomib
• •No other concurrent investigational agents
• •No other concurrent clinical research study participation
• •No other concurrent antineoplastic therapy
• •No concurrent routine use of anti-inflammatory drugs, including cyclo-oxygenase inhibitors (e.g., celecoxib or rofecoxib)