Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer
Condition: 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
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar
Intervention: bortezomib
Intervention description: Given IV
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well bortezomib works in treating patients with stage
      IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some
      of the enzymes needed for cell growth.
    

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