Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IV non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following cellular types: Adenocarcinoma Large cell Squamous cell Mixed Meets 1 of the following staging criteria: Stage IIIB disease with malignant pleural effusion, supraclavicular node involvement, or contralateral hilar nodes Stage IIIB patients eligible for Cancer and Leukemia Group B protocols of combined chemotherapy and chest irradiation are not allowed Stage IV disease Measurable or nonmeasurable disease Unidimensionally measurable lesions at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan The following are considered nonmeasurable disease: Bone lesions Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Small lesions No leptomeningeal disease Symptomatic CNS metastases must be treated (e.g., surgery, radiotherapy, or gamma knife), neurologically stable, and off steroids PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 mg/dL AST no greater than 2.0 times upper limit of normal Renal Creatinine no greater than 1.5 mg/dL Cardiovascular None of the following within the past 6 months: Myocardial infarction Unstable angina Symptomatic congestive heart failure Serious uncontrolled cardiac arrhythmia Cerebrovascular accident Transient ischemic attack Symptomatic carotid artery or peripheral vascular disease Deep vein thrombosis Significant thromboembolic event Pulmonary No pulmonary embolism within the past 6 months Gastrointestinal No history of gastrointestinal (GI) bleeding No history of peptic ulcer disease No active GI bleeding Other Not pregnant or nursing No known hypersensitivity to aspirin, NSAIDs, or sulfonamides No currently active second malignancy other than nonmelanoma skin cancer Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for NSCLC Chemotherapy No prior chemotherapy for NSCLC No other concurrent chemotherapy Endocrine therapy See Disease Characteristics No concurrent chronic oral steroids Concurrent episodic steroids for antiemetic purposes allowed No concurrent hormonal therapy Concurrent inhaled steroids allowed when medically indicated Concurrent megestrol for appetite stimulation is allowed Radiotherapy See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered Surgery See Disease Characteristics At least 2 weeks since prior surgery and recovered Other No prior systemic treatments for NSCLC No other concurrent investigational therapy At least 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs), including any of the following: Rofecoxib Choline magnesium trisalicylate Ibuprofen Naproxen Etodolac Oxaprozin Diflunisal Nabumetone Tolmetin Valdecoxib No concurrent NSAIDs No concurrent chronic aspirin Concurrent aspirin no greater than 325 mg/day is allowed No concurrent fluconazole No concurrent leukotriene antagonists (e.g., zafirlukast, montelukast, or pranlukast)
Sites / Locations
- Northeast Alabama Regional Medical Center
- Rebecca and John Moores UCSD Cancer Center
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
- Naval Medical Center - San Diego
- Veterans Affairs Medical Center - San Diego
- UCSF Comprehensive Cancer Center
- Veterans Affairs Medical Center - San Francisco
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center at Georgetown University Medical Center
- Walter Reed Army Medical Center
- Veterans Affairs Medical Center - Washington, DC
- Broward General Medical Center
- Memorial Regional Cancer Center at Memorial Regional Hospital
- CCOP - Mount Sinai Medical Center
- Palm Beach Cancer Institute
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- CCOP - Evanston
- CCOP - Illinois Oncology Research Association
- West Suburban Center for Cancer Care
- Fort Wayne Medical Oncology and Hematology, Incorporated
- CCOP - Northern Indiana CR Consortium
- Holden Comprehensive Cancer Center at University of Iowa
- Baptist Hospital East - Louisville
- Greenebaum Cancer Center at University of Maryland Medical Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- University of Massachusetts Memorial Medical Center - University Campus
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- CCOP - Kansas City
- Siteman Cancer Center
- Missouri Baptist Cancer Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - Las Vegas
- New Hampshire Oncology-Hematology, PA - Hooksett
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Cooper University Hospital
- Veterans Affairs Medical Center - Buffalo
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Queens Cancer Center of Queens Hospital
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- Mount Sinai Medical Center
- University Hospital at State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- Veterans Affairs Medical Center - Asheville
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- NorthEast Oncology Associates - Concord
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- Cape Fear Valley Health System
- CCOP - Southeast Cancer Control Consortium
- FirstHealth Moore Regional Hospital
- Zimmer Cancer Center at New Hanover Regional Medical Center
- Comprehensive Cancer Center at Wake Forest University
- Arthur G. James Cancer Hospital at Ohio State University
- Oklahoma University Medical Center
- Western Pennsylvania Hospital
- Lifespan: The Miriam Hospital
- Veterans Affairs Medical Center - Dallas
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Vermont Cancer Center at University of Vermont
- Martha Jefferson Hospital
- Virginia Oncology Associates - Norfolk
- MBCCOP - Massey Cancer Center
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
- St. Mary's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Gem + Carboplatin + Zileuton
Gem + Carboplatin + celecoxib
Gem + carboplatin + zilueton + celecoxib