Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: docetaxel; bortezomib; laboratory biomarker analysis; immunoenzyme technique; immunohistochemistry staining method; pharmacological study
Intervention description: Given IV; Given IV; correlative study; correlative study; correlative study; correlative study
Intervention MeSH terms: Docetaxel; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      This trial is studying two different schedules of docetaxel and bortezomib to compare how
      well they work in treating patients with progressive or recurrent non-small cell lung cancer.
      Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of
      tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may
      stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
      docetaxel together with bortezomib may kill more tumor cells
    

Eligibility criteria:

        Criteria:

          -  No other prior malignancy except adequately treated basal cell or squamous cell skin
             cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the
             patient is currently in complete remission, or any other cancer for which the patient
             has been disease-free for 5 years.

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).

          -  Progressive or recurrent NSCLC after treatment with 1 prior platinum-based
             chemotherapy regimen for metastatic disease. Prior neoadjuvant/adjuvant chemotherapy
             and/or concurrent chemoradiation for early-stage disease allowed.

          -  At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
             and recovered.

          -  No prior docetaxel or bortezomib

          -  Prior epidermal growth factor receptor inhibitor therapy allowed.

          -  Prior paclitaxel allowed

          -  At least 4 weeks since prior major surgery and recovered.

          -  At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsants.

          -  No concurrent hormonal therapy, biologic therapy, or radiotherapy to measurable
             lesions. Concurrent palliative radiotherapy to small-field nonindicator lesions (e.g.,
             painful bony metastases) allowed.

          -  Measurable disease* with >= 1 unidimensionally objectively measurable lesion,
             including any of the following:

          -  Lung mass (measurable on chest x-ray, tomograms, or CT scan)

          -  Enlarged lymph nodes

          -  Liver metastasis (measurable as a discrete focal lesion on radionuclide or CT scan, or
             ultrasound)

          -  Metastatic abdominal mass (measurable on CT scan with >= 1 perpendicular diameter ≥
             the distance between cuts)

          -  Measurable disease must be outside the previous radiation field or a new lesion must
             be present.

          -  Life expectancy >= 12 weeks

          -  Progressive disease within a previously radiated field allowed.

          -  [Note: *Measurable disease DOES NOT include bone metastases or non-focal liver
             metastases].

          -  No symptomatic or untreated brain metastasis requiring steroids. Asymptomatic,
             previously treated (surgical resection or radiotherapy) brain metastasis allowed
             provided they are neurologically stable and >= 4 weeks since prior steroids.

          -  Creatinine clearance >= 50 mL/min

          -  Creatinine =< 1.6 mg/dL

          -  Bilirubin normal

          -  AST =< 2 times upper limit of normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No peripheral neuropathy >= grade 2

          -  Absolute granulocyte count >= 1,500/mm³

          -  Platelet count >= 100,000/mm³

          -  Cutaneous nodule

          -  ECOG performance status 0-1

          -  At least 4 weeks since prior radiotherapy and recovered.