Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer
Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
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.
Sites / Locations
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm 1
Arm 2
Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8.
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.