Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer
Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Lung
Eligibility Criteria
Criteria: Histologically confirmed bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features: Stage IIIB or IV disease: Patients with stage IIIB disease must be ineligible for definitive combined modality treatment with radiotherapy and chemotherapy Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan: Previously irradiated lesions are considered measurable only if lesion progressed after completion of radiotherapy No unstable brain metastases: Brain metastases that are stable for ≥ 1 month after completion of prior radiotherapy, stereotactic surgery, or surgery are allowed Performance status: ECOG 0-2 Life expectancy >3 months Hepatic: Bilirubin normal AST and ALT =< 2.5 times upper limit of normal Renal: Creatinine normal OR creatinine clearance >= 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmias No more than 1 prior chemotherapy regimen for advanced BAC: Prior gefitinib or other known epidermal growth factor receptor (EGFR) inhibitors are not considered a systemic chemotherapy regimen At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) At least 4 weeks since prior corticosteroids Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception before, during, and for 30 days after completion of study treatment No ongoing or active infection No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is in complete remission No peripheral neuropathy >= grade 2 No known hypersensitivity to bortezomib, boron, or mannitol No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness No concurrent routine granulocyte colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) At least 2 weeks since prior radiotherapy Recovered from prior therapy (alopecia allowed) At least 2 weeks since prior EGFR inhibitors At least 4 weeks since prior anticonvulsants No prior bortezomib No concurrent antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer therapy Concurrent bisphosphonates for bone metastases allowed Hematopoietic: Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3
Sites / Locations
- City of Hope
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8.