Clinical trial NCT00118144 (phase 2, status: completed)
Conditions: adenocarcinoma of the lung, bronchoalveolar cell lung cancer, non-small cell lung cancer, recurrent non-small cell lung cancer, stage iiib non-small cell lung cancer, stage iv non-small cell lung cancer
ICD codes: D02.20, D02.21, D02.22, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: bortezomib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
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