Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib 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 adenocarcinoma of the lung, adenosquamous cell lung cancer, large cell lung cancer, squamous cell lung cancer, recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell carcinoma of the lung, including the following cell types:
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Mixture of these types
- A tissue block must be available at the time of registration
- Tumor expresses COX-2 (COX-2 index ≥ 2)
Stage IIIB disease with malignant pleural effusion, supraclavicular node involvement, or contralateral hilar node involvement OR stage IV disease
- Patients with stage IIIB disease who are eligible for clinical trials that involve combined chemotherapy and chest irradiation are not eligible for this study
- Patients with stage IV disease are eligible
- Patients with recurrent disease, not amenable to (or refusing) a potentially "curative therapy," are eligible
Measurable or non-measurable disease
- Measurable disease is defined as lesions that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT scan
Non-measurable disease is defined as all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions, including any of the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
Patients with symptomatic CNS metastases are eligible provided they received prior therapy (e.g., surgery, radiotherapy, or gamma knife), are neurologically stable, and are off steroids for ≥ 14 days before study entry
- Patients with asymptomatic CNS metastases without associated edema, shift, or requirement for steroids or antiseizure medications may be eligible after discussion with the Study Chair
- Patients should be off steroids at least 7 days before preregistration
- No leptomeningeal disease or carcinomatous meningitis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Granulocytes ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Creatinine clearance ≥ 45 mL/min
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.0 times upper limit of normal (ULN) (≤ 5.0 times ULN if liver metastases are present)
- Serum albumin ≥ 2.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
No "currently active" second malignancy other than non-melanoma 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 < 30% risk of relapse
- No known hypersensitivity to aspirin, NSAIDs, or sulfonamides
No active ulcer disease
- No history of gastrointestinal bleeding within the past three years
None of the following cardiovascular conditions within the past 6 months:
- Myocardial infarction
- Unstable angina
- Symptomatic congestive heart failure
- Serious uncontrolled cardiac arrhythmia
- Cerebrovascular accident or transient ischemic attack
- Pulmonary embolism
- Symptomatic carotid artery or peripheral vascular disease
- Deep vein thrombosis
- Other significant thromboembolic event
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy, immunotherapy, or other systemic therapy for non-small cell lung cancer, including adjuvant therapy
- At least 2 weeks since prior surgery and recovered
- At least 7 days since prior radiotherapy
At least 14 days since prior NSAIDs (other than low-dose aspirin [≤ 325 mg daily]), including any of the following:
- Celecoxib
- Choline Mg
- Trisalicylate (Trilisate®)
- Ibuprofen (Advil® or Motrin®)
- Naproxen (Aleve®, Naprosyn® or Anaprox®)
- Etodolac (Lodine®)
- Oxaprozin (Daypro®)
- Diflunisal (Dolobid®)
- Nabumetone (Relafen®)
- Tolmetin (Tolectin®)
- Valdecoxib (Bextra®)
No chronic use of NSAIDs (i.e., > 4 weeks of daily use)
- Patients on low-dose aspirin are eligible
- No other concurrent chemotherapy or hormonal therapy (other than megestrol acetate [Megace] for appetite stimulation)
- No other concurrent investigational therapy
Sites / Locations
- Regional Medical Center
- Mayo Clinic Scottsdale
- NEA Medical Clinic - East Matthews
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- City of Hope Comprehensive Cancer Center
- Rebecca and John Moores UCSD Cancer Center
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
- Camino Medical Group - Treatment Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation
- Feather River Hospital Cancer Center
- PCR Oncology
- Naval Medical Center - San Diego
- UCSF Helen Diller Family Comprehensive Cancer Center
- Veterans Affairs Medical Center - San Francisco
- Poudre Valley Hospital
- Front Range Cancer Specialists
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Middlesex Hospital Cancer Center
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Washington Cancer Institute at Washington Hospital Center
- Veterans Affairs Medical Center - Washington, DC
- North Broward Medical Center
- Florida Hospital - Orlando
- John B. Amos Cancer Center
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Dwight David Eisenhower Army Medical Center
- Northeast Georgia Medical Center
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Kapiolani Medical Center at Pali Momi
- Cancer Research Center of Hawaii
- Oncare Hawaii Inc-POB II
- OnCare Hawaii, Incorporated - Lusitana
- Queen's Cancer Institute at Queen's Medical Center
- Straub Clinic and Hospital, Incorporated
- University of Hawaii
- OnCare Hawaii, Incorporated - Kuakini
- Hawaii Medical Center - East
- OnCare Hawaii-Liliha
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Castle Medical Center
- Kauai Medical Clinic
- Maui Memorial Medical Center
- Pacific Cancer Institute - Maui
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Saint Joseph Regional Medical Center
- Rush-Copley Cancer Care Center
- Illinois CancerCare - Bloomington
- St. Joseph Medical Center
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- University of Illinois Cancer Center
- Resurrection Medical Center
- University of Chicago Cancer Research Center
- Eureka Community Hospital
- Illinois CancerCare - Eureka
- Evanston Hospital
- Galesburg Clinic, PC
- Illinois CancerCare - Havana
- Illinois CancerCare - Kewanee Clinic
- La Grange Memorial Hospital
- Illinois CancerCare - Macomb
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- Illinois CancerCare - Monmouth
- OSF Holy Family Medical Center
- Hematology Oncology Consultants - Naperville
- BroMenn Regional Medical Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Advocate Christ Medical Center
- Community Hospital of Ottawa
- Illinois CancerCare-Ottawa Clinic
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Ottawa Regional Hospital and Healthcare Center
- Cancer Treatment Center at Pekin Hospital
- Pekin Cancer Treatment Center
- Illinois CancerCare - Pekin
- Methodist Medical Center of Illinois
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Illinois CancerCare-Peoria
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- OSF St. Francis Medical Center
- Illinois CancerCare - Peru
- Illinois Valley Community Hospital
- Illinois CancerCare - Princeton
- Swedish-American Regional Cancer Center
- Illinois CancerCare - Spring Valley
- CCOP - Carle Cancer Center
- St. Francis Hospital Cancer Care Services
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services
- McFarland Clinic, PC
- Constantinou, Costas L MD (UIA Investigator)
- Hematology Oncology Associates of the Quad Cities
- Helen G Nassif Community Cancer Center
- Iowa Blood and Cancer Care
- St. Luke's Hospital
- Mercy Regional Cancer Center at Mercy Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Mercy Cancer Center - West Lakes
- Genesis Regional Cancer Center at Genesis Medical Center
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Holden Comprehensive Cancer Center at University of Iowa
- Veterans Affairs Medical Center - Iowa City
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Methodist West Hospital
- Stormont-Vail Regional Health Center
- Central Baptist Hospital
- Mary Bird Perkins Cancer Center - Baton Rouge
- Louisiana State University Health Sciences Center - Monroe
- Interim LSU Public Hospital
- Louisiana State University Health Science Center
- Highland Clinic
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Harold Alfond Center for Cancer Care
- CancerCare of Maine at Eastern Maine Medical Center
- Eastern Maine Medical Center
- Greenebaum Cancer Center at University of Maryland Medical Center
- Veterans Affairs Medical Center - Baltimore
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- National Naval Medical Center
- Union Hospital of Cecil County
- John R. Marsh Cancer Center at Washington County Hospital
- Meritus Medical Center
- Beverly Hospital
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
- Boston University Cancer Research Center
- Caritas St. Elizabeth's Medical Center
- Addison Gilbert Hospital
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
- Dana-Farber/Brigham and Women's Cancer Center at South Shore
- Hickman Cancer Center at Bixby Medical Center
- Toledo Clinic Cancer Centers - Adrian
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Oakwood Hospital
- Saint John Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Genesys Regional Medical Center
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Spectrum Health at Butterworth Campus
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- Toledo Clinic Cancer Centers - Monroe
- Mercy General Health Partners
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Spectrum Health Reed City Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- Munson Medical Center
- St. John Macomb Hospital
- Sanford Clinic North-Bemidji
- St. Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Essentia Health - Duluth Clinic
- CCOP - Duluth
- Miller - Dwan Medical Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Masonic Cancer Center at University of Minnesota
- New Ulm Medical Center
- Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology - Woodbury
- University of Mississippi Cancer Clinic
- Regional Cancer Center at Singing River Hospital
- Central Care Cancer Center at Carrie J. Babb Cancer Center
- Cox Cancer Center Branson
- Skaggs Cancer Center at Skaggs Regional Medical Center
- Southeast Cancer Center
- Veterans Administration/Harry S Truman Memorial Hospital
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Goldschmidt Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Washington University School of Medicine
- Missouri Baptist Cancer Center
- CCOP - Cancer Research for the Ozarks
- Mercy-Springfield
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Benefis Sletten Cancer Institute
- Great Falls Clinic - Main Facility
- St. Peter's Hospital
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Renown Institute for Cancer at Renown Regional Medical Center
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
- Center for Cancer Care at Exeter Hospital
- New Hampshire Oncology - Hematology, PA - Hooksett
- Lakes Region General Hospital
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Dana-Farber Cancer Institute at Londonderry
- Norris Cotton Cancer Center-Manchester
- Cooper Hospital University Medical Center
- Veterans Administration New Jersey Health Care System
- Newark Beth Israel Medical Center
- Valley Hospital - Ridgewood
- Cancer Institute of New Jersey at Cooper - Voorhees
- Veterans Affairs Medical Center - Brooklyn
- Veterans Affairs Medical Center - Buffalo
- CCOP - Hematology-Oncology Associates of Central New York
- Charles R. Wood Cancer Center at Glens Falls Hospital
- Monter Cancer Center of the North Shore-LIJ Health System
- CCOP - North Shore University Hospital
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
- Orange Regional Medical Center
- Long Island Jewish Medical Center
- New York Weill Cornell Cancer Center at Cornell University
- Lipson Cancer and Blood Center at Rochester General Hospital
- SUNY Upstate Medical University Hospital
- Veterans Affairs Medical Center - Syracuse
- Mission Hospitals - Memorial Campus
- Veterans Affairs Medical Center - Durham
- Duke Cancer Institute
- Wayne Memorial Hospital, Incorporated
- Kinston Medical Specialists
- Southeastern Regional Medical Center
- Granville Medical Center
- FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
- Duke Health Raleigh Hospital
- Person Memorial Hospital
- Iredell Memorial Hospital
- Marion L. Shepard Cancer Center at Beaufort County Hospital
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- Sanford Bismarck Medical Center
- St. Alexius Medical Center Cancer Center
- Sanford Clinic North-Fargo
- Dakota Cancer Institute at Dakota Clinic - South University
- Essentia Health Cancer Center-South University Clinic
- Sanford Clinic North-Fargo
- Sanford Roger Maris Cancer Center
- Altru Cancer Center at Altru Hospital
- Trinity CancerCare Center
- Wood County Oncology Center
- Charles M. Barrett Cancer Center at University Hospital
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Dayton CCOP
- Community Cancer Center
- Hematology Oncology Center
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- St. Rita's Medical Center
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- Toledo Clinic Cancers Centers - Maumee
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- University of Toledo
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Cancer Centers of Southwest Oklahoma, LLC - Lawton
- Mercy Clinic Oklahoma Communities Inc-Norman
- Oklahoma University Cancer Institute
- Mercy Clinic Oklahoma Communities Inc-Mercy Health Center
- Celilo Cancer Center at Mid-Columbia Medical Center
- Rosenfeld Cancer Center at Abington Memorial Hospital
- Rhode Island Hospital Comprehensive Cancer Center
- Miriam Hospital
- McLeod Regional Medical Center
- Rapid City Regional Hospital
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Veterans Affairs Medical Center - White River Junction
- White River Junction Veteran Administration Medical Center
- Danville Regional Medical Center
- Fredericksburg Oncology, Incorporated
- Lynchburg Hematology-Oncology Clinic
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
- Southwest Virginia Regional Cancer Center at Wellmonth Health
- Island Hospital Cancer Care Center at Island Hospital
- Auburn Regional Center for Cancer Care
- Overlake Cancer Center at Overlake Hospital Medical Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Highline Medical Center Cancer Center
- Providence Centralia Hospital
- Swedish Medical Center-Edmonds
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Medical Center - Issaquah Campus
- Columbia Basin Hematology
- Skagit Valley Hospital Cancer Care Center
- Providence St. Peter Hospital Regional Cancer Center
- Harrison Poulsbo Hematology and Onocology
- Good Samaritan Cancer Center
- Harborview Medical Center
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology, PS
- Allenmore Hospital
- Northwest CCOP
- Saint Joseph Medical Center
- Multicare Health System - Tacoma General Hospital
- Saint Clare Hospital
- Wenatchee Valley Medical Center
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- Marshfield Clinic - Chippewa Center
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Mercy Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Marshfield Clinic - Marshfield Center
- Marshfield Clinic - Minocqua Center
- D.N. Greenwald Center
- Westfields Hospital/Cancer Center of Western Wisconsin
- Regional Cancer Center at Oconomowoc Memorial Hospital
- Green Bay Oncology, Limited - Oconto Falls
- Marshfield Clinic at James Beck Cancer Center
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Rice Lake Center
- St. Nicholas Hospital
- Marshfield Clinic at Saint Michael's Hospital
- Green Bay Oncology, Limited - Sturgeon Bay
- Waukesha Memorial Hospital Regional Cancer Center
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I
Arm II
Patients receive gemcitabine hydrochloride* IV on days 1 and 8 OR pemetrexed disodium* IV on day 1. Patients also receive carboplatin IV on day 1 and oral celecoxib twice daily on days 1-21.
Patients receive gemcitabine hydrochloride* OR pemetrexed disodium* and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 1-21.