Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Locally advanced (stage IIIB) or metastatic (stage IV) disease Inoperable disease Relapsed or refractory disease Received 1, and only 1, prior chemotherapy regimen for locally advanced or metastatic disease Measurable or evaluable disease No symptomatic or inadequately treated brain metastases No CNS disease PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 70-100% Life expectancy More than 3 months Hematopoietic Platelet count greater than 100,000/mm^3 Hemoglobin greater than 8.0 g/dL Absolute neutrophil count greater than 1,500/mm^3 Hepatic AST and ALT less than 3 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Hepatitis B surface antigen negative Hepatitis C negative Renal Creatinine less than 1.8 mg/dL Cardiovascular No myocardial infarction within the past 6 months No New York Heart Association class III or IV heart failure No uncontrolled angina No severe uncontrolled ventricular arrhythmias No electrocardiographic evidence of acute ischemia or active conduction system abnormalities No poorly controlled hypertension Immunologic No active systemic infection requiring treatment No prior allergic reaction attributable to compounds containing boron or mannitol HIV negative Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No peripheral neuropathy grade 2 or greater No diabetes mellitus No other serious medical or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy More than 6 weeks since prior monoclonal antibody therapy No concurrent routine use of colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) No concurrent immunotherapy Chemotherapy See Disease Characteristics More than 4 weeks since prior chemotherapy No prior docetaxel Prior paclitaxel allowed No other concurrent chemotherapy Endocrine therapy No concurrent corticosteroids (e.g., prednisone or prednisolone) except dexamethasone as premedication Radiotherapy More than 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery More than 4 weeks since prior major surgery No concurrent surgery for cancer management or treatment Other More than 5 years since prior treatment for any other cancer except basal cell skin cancer or carcinoma in situ of the cervix More than 4 weeks since prior investigational agents No prior bortezomib No other concurrent investigational agents No other concurrent clinical research study participation No other concurrent antineoplastic therapy No concurrent routine use of anti-inflammatory drugs, including cyclo-oxygenase inhibitors (e.g., celecoxib or rofecoxib)
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
- Jonsson Comprehensive Cancer Center, UCLA
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Yale Comprehensive Cancer Center
- University of Miami Sylvester Cancer Center
- Winship Cancer Institute of Emory University
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Massachusetts General Hospital Cancer Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Kansas City Cancer Centers - Central
- Siteman Cancer Center
- St. Louis University Hospital Cancer Center
- Blumenthal Cancer Center at Carolinas Medical Center
- Duke Comprehensive Cancer Center
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
- University of Texas - MD Anderson Cancer Center
- Huntsman Cancer Institute
- University of Wisconsin Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Velcade Alone
Velcade plus Docetaxel
Velcade
Velcade plus Docetaxel