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Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer

26. juni 2018 opdateret af: Alliance for Clinical Trials in Oncology

A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more effective with or without celecoxib in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed disodium, and carboplatin to compare how well they work when given together with celecoxib or a placebo in treating patients with advanced non-small cell lung cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Lungekræft

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

To confirm the beneficial effect of gemcitabine hydrochloride or pemetrexed disodium in combination with carboplatin with or without celecoxib in patients with advanced non-small cell lung cancer that expresses COX-2.

Secondary

To describe the response rate in patients treated with these regimens.
To describe the distribution of progression-free survival (PFS) and overall survival of patients treated with these regimens.
To compare the PFS of patients with COX-2 index ≥ 2 (adjusting for CYP2C9 genotype and celecoxib trough concentrations as covariates) treated with these regimens.
To correlate urinary PGE-M level with COX-2 expression, COX-2 inhibition, and outcome.
To evaluate the association between the -765G/C polymorphism in PTGS2 and COX-2 expression in non-small cell lung cancer specimens.
To characterize a trough plasma celecoxib concentration which will be used as a measure of patient adherence to study treatment and which may be used in future studies for correlations with genotype and pharmacodynamic outcomes.

OUTLINE: This is a multicenter study. Patients are stratified according to gender, disease stage (IIIB vs IV), histology (squamous cell carcinoma vs non-squamous cell carcinoma), smoking status (never/former light smoker [defined as ≤ 10 pack years AND quit ≥ 1 year ago] vs smoker), and COX-2 expression status (COX-2 index ≥ 4 vs COX-2 index ≥ 2 but < 4). Patients are randomized to 1 of 2 treatment arms.

Arm I: 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.
Arm II: Patients receive gemcitabine hydrochloride* OR pemetrexed disodium* and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 1-21.
NOTE: *Patients with squamous cell carcinoma receive gemcitabine hydrochloride; patients with non-squamous cell carcinoma receive pemetrexed disodium.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with responding or stable disease may continue to receive celecoxib or placebo alone in the absence of disease progression or unacceptable toxicity.

Patients may undergo blood and urine sample collection periodically for correlative laboratory studies.

After completion of study therapy, patients are followed up every 2 months for 2 years and then every 6 months for 3 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

313

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Anniston, Alabama, Forenede Stater, 36207
    - Regional Medical Center
- Arizona
  - Scottsdale, Arizona, Forenede Stater, 85259-5499
    - Mayo Clinic Scottsdale
- Arkansas
  - Jonesboro, Arkansas, Forenede Stater, 72401
    - NEA Medical Clinic - East Matthews
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Duarte, California, Forenede Stater, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - La Jolla, California, Forenede Stater, 92093-0658
    - Rebecca and John Moores UCSD Cancer Center
  - Los Angeles, California, Forenede Stater, 90048
    - Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  - Mountain View, California, Forenede Stater, 94040
    - Palo Alto Medical Foundation-Camino Division
  - Mountain View, California, Forenede Stater, 94040
    - Camino Medical Group - Treatment Center
  - Palo Alto, California, Forenede Stater, 94301
    - Palo Alto Medical Foundation
  - Paradise, California, Forenede Stater, 95969
    - Feather River Hospital Cancer Center
  - Pismo Beach, California, Forenede Stater, 93449
    - PCR Oncology
  - San Diego, California, Forenede Stater, 92134
    - Naval Medical Center - San Diego
  - San Francisco, California, Forenede Stater, 94121
    - Veterans Affairs Medical Center - San Francisco
  - San Francisco, California, Forenede Stater, 94115
    - UCSF Helen Diller Family Comprehensive Cancer Center
- Colorado
  - Fort Collins, Colorado, Forenede Stater, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, Forenede Stater, 80528
    - Front Range Cancer Specialists
- Connecticut
  - Hartford, Connecticut, Forenede Stater, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  - Middletown, Connecticut, Forenede Stater, 06457
    - Middlesex Hospital Cancer Center
- Delaware
  - Lewes, Delaware, Forenede Stater, 19958
    - Tunnell Cancer Center at Beebe Medical Center
  - Newark, Delaware, Forenede Stater, 19713
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20422
    - Veterans Affairs Medical Center - Washington, DC
  - Washington, District of Columbia, Forenede Stater, 20010
    - Washington Cancer Institute at Washington Hospital Center
- Florida
  - Deerfield Beach, Florida, Forenede Stater, 33064-3596
    - North Broward Medical Center
  - Orlando, Florida, Forenede Stater, 32803
    - Florida Hospital - Orlando
- Georgia
  - Columbus, Georgia, Forenede Stater, 31904
    - John B. Amos Cancer Center
  - Decatur, Georgia, Forenede Stater, 30033
    - Veterans Affairs Medical Center - Atlanta (Decatur)
  - Fort Gordon, Georgia, Forenede Stater, 30905-5650
    - Dwight David Eisenhower Army Medical Center
  - Gainesville, Georgia, Forenede Stater, 30501
    - Northeast Georgia Medical Center
  - Savannah, Georgia, Forenede Stater, 31403-3089
    - Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Hawaii
  - 'Aiea, Hawaii, Forenede Stater, 96701
    - Kapiolani Medical Center at Pali Momi
  - Honolulu, Hawaii, Forenede Stater, 96817
    - The Cancer Center of Hawaii-Liliha
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, Forenede Stater, 96813
    - OnCare Hawaii, Incorporated - Lusitana
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, Forenede Stater, 96817
    - Hawaii Medical Center - East
  - Honolulu, Hawaii, Forenede Stater, 96813
    - University of Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Oncare Hawaii Inc-POB II
  - Honolulu, Hawaii, Forenede Stater, 96817
    - OnCare Hawaii-Liliha
  - Honolulu, Hawaii, Forenede Stater, 96817-3169
    - OnCare Hawaii, Incorporated - Kuakini
  - Kailua, Hawaii, Forenede Stater, 96734
    - Castle Medical Center
  - Lihue, Hawaii, Forenede Stater, 96766
    - Kauai Medical Clinic
  - Wailuku, Hawaii, Forenede Stater, 96793
    - Maui Memorial Medical Center
  - Wailuku, Hawaii, Forenede Stater, 96793
    - Pacific Cancer Institute - Maui
- Idaho
  - Boise, Idaho, Forenede Stater, 83706
    - Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
  - Lewiston, Idaho, Forenede Stater, 83501
    - Saint Joseph Regional Medical Center
- Illinois
  - Aurora, Illinois, Forenede Stater, 60504
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, Forenede Stater, 61701
    - Illinois CancerCare - Bloomington
  - Bloomington, Illinois, Forenede Stater, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, Forenede Stater, 61520
    - Illinois CancerCare - Canton
  - Carthage, Illinois, Forenede Stater, 62321
    - Illinois CancerCare - Carthage
  - Chicago, Illinois, Forenede Stater, 60637-1470
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, Forenede Stater, 60612-7243
    - University of Illinois Cancer Center
  - Chicago, Illinois, Forenede Stater, 60631
    - Resurrection Medical Center
  - Eureka, Illinois, Forenede Stater, 61530
    - Illinois CancerCare - Eureka
  - Eureka, Illinois, Forenede Stater, 61530
    - Eureka Community Hospital
  - Evanston, Illinois, Forenede Stater, 60201-1781
    - Evanston Hospital
  - Galesburg, Illinois, Forenede Stater, 61401
    - Galesburg Clinic, PC
  - Havana, Illinois, Forenede Stater, 62644
    - Illinois CancerCare - Havana
  - Kewanee, Illinois, Forenede Stater, 61443
    - Illinois CancerCare - Kewanee Clinic
  - La Grange, Illinois, Forenede Stater, 60525
    - La Grange Memorial Hospital
  - Macomb, Illinois, Forenede Stater, 61455
    - Illinois CancerCare - Macomb
  - Moline, Illinois, Forenede Stater, 61265
    - Garneau, Stewart C MD (UIA Investigator)
  - Moline, Illinois, Forenede Stater, 61265
    - Spector, David MD (UIA Investigator)
  - Moline, Illinois, Forenede Stater, 61265
    - Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  - Moline, Illinois, Forenede Stater, 61265
    - Porubcin, Michael (UIA Investigator)
  - Monmouth, Illinois, Forenede Stater, 61462
    - Illinois CancerCare - Monmouth
  - Monmouth, Illinois, Forenede Stater, 61462
    - OSF Holy Family Medical Center
  - Naperville, Illinois, Forenede Stater, 60540
    - Hematology Oncology Consultants - Naperville
  - Normal, Illinois, Forenede Stater, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Forenede Stater, 61761
    - Community Cancer Center
  - Normal, Illinois, Forenede Stater, 61761
    - Illinois CancerCare - Community Cancer Center
  - Oak Lawn, Illinois, Forenede Stater, 60453-2699
    - Advocate Christ Medical Center
  - Ottawa, Illinois, Forenede Stater, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa, Illinois, Forenede Stater, 61350
    - Ottawa Regional Hospital and Healthcare Center
  - Ottawa, Illinois, Forenede Stater, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, Forenede Stater, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, Forenede Stater, 61554
    - Pekin Cancer Treatment Center
  - Pekin, Illinois, Forenede Stater, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Pekin, Illinois, Forenede Stater, 61603
    - Illinois CancerCare - Pekin
  - Peoria, Illinois, Forenede Stater, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, Forenede Stater, 61614
    - Proctor Hospital
  - Peoria, Illinois, Forenede Stater, 61603
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Forenede Stater, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, Forenede Stater, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, Forenede Stater, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, Forenede Stater, 61354
    - Illinois CancerCare - Peru
  - Peru, Illinois, Forenede Stater, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, Forenede Stater, 61356
    - Illinois CancerCare - Princeton
  - Rockford, Illinois, Forenede Stater, 61104-2315
    - Swedish-American Regional Cancer Center
  - Spring Valley, Illinois, Forenede Stater, 61362
    - Illinois CancerCare - Spring Valley
  - Urbana, Illinois, Forenede Stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46237
    - St. Francis Hospital Cancer Care Services
  - Michigan City, Indiana, Forenede Stater, 46360
    - Saint Anthony Memorial Health Centers
  - Richmond, Indiana, Forenede Stater, 47374
    - Reid Hospital & Health Care Services
- Iowa
  - Ames, Iowa, Forenede Stater, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, Forenede Stater, 52722
    - Constantinou, Costas L MD (UIA Investigator)
  - Bettendorf, Iowa, Forenede Stater, 52722
    - Hematology Oncology Associates of the Quad Cities
  - Cedar Rapids, Iowa, Forenede Stater, 52402
    - St. Luke's Hospital
  - Cedar Rapids, Iowa, Forenede Stater, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Cedar Rapids, Iowa, Forenede Stater, 52402
    - Iowa Blood and Cancer Care
  - Cedar Rapids, Iowa, Forenede Stater, 52402
    - Helen G Nassif Community Cancer Center
  - Clive, Iowa, Forenede Stater, 50325
    - Medical Oncology and Hematology Associates - West Des Moines
  - Clive, Iowa, Forenede Stater, 50325
    - Mercy Cancer Center - West Lakes
  - Davenport, Iowa, Forenede Stater, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
  - Des Moines, Iowa, Forenede Stater, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, Forenede Stater, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Forenede Stater, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, Forenede Stater, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, Forenede Stater, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Forenede Stater, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Iowa City, Iowa, Forenede Stater, 52242-1002
    - Holden Comprehensive Cancer Center at University of Iowa
  - Iowa City, Iowa, Forenede Stater, 52246
    - Veterans Affairs Medical Center - Iowa City
  - Mason City, Iowa, Forenede Stater, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Ottumwa, Iowa, Forenede Stater, 52501
    - McCreery Cancer Center at Ottumwa Regional
  - Sioux City, Iowa, Forenede Stater, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, Forenede Stater, 51102
    - Mercy Medical Center - Sioux City
  - Sioux City, Iowa, Forenede Stater, 51104
    - St. Luke's Regional Medical Center
  - West Des Moines, Iowa, Forenede Stater, 50266-7700
    - Methodist West Hospital
- Kansas
  - Topeka, Kansas, Forenede Stater, 66604
    - Stormont-Vail Regional Health Center
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40503-9985
    - Central Baptist Hospital
- Louisiana
  - Baton Rouge, Louisiana, Forenede Stater, 70809
    - Mary Bird Perkins Cancer Center - Baton Rouge
  - Monroe, Louisiana, Forenede Stater, 71210
    - Louisiana State University Health Sciences Center - Monroe
  - New Orleans, Louisiana, Forenede Stater, 70112
    - Louisiana State University Health Science Center
  - New Orleans, Louisiana, Forenede Stater, 70112
    - Interim LSU Public Hospital
  - Shreveport, Louisiana, Forenede Stater, 71105
    - Highland Clinic
  - Shreveport, Louisiana, Forenede Stater, 71130-3932
    - Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Maine
  - Augusta, Maine, Forenede Stater, 04330
    - Harold Alfond Center for Cancer Care
  - Bangor, Maine, Forenede Stater, 04401
    - Eastern Maine Medical Center
  - Bangor, Maine, Forenede Stater, 04401
    - CancerCare of Maine at Eastern Maine Medical Center
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21201
    - Veterans Affairs Medical Center - Baltimore
  - Baltimore, Maryland, Forenede Stater, 21215
    - Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  - Baltimore, Maryland, Forenede Stater, 21201
    - Greenebaum Cancer Center at University of Maryland Medical Center
  - Bethesda, Maryland, Forenede Stater, 20889-5600
    - National Naval Medical Center
  - Elkton, Maryland, Forenede Stater, 21921
    - Union Hospital of Cecil County
  - Hagerstown, Maryland, Forenede Stater, 21742
    - Meritus Medical Center
  - Hagerstown, Maryland, Forenede Stater, 21740
    - John R. Marsh Cancer Center at Washington County Hospital
- Massachusetts
  - Beverly, Massachusetts, Forenede Stater, 01915
    - Beverly Hospital
  - Boston, Massachusetts, Forenede Stater, 02118
    - Boston University Cancer Research Center
  - Boston, Massachusetts, Forenede Stater, 02115
    - Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
  - Brighton, Massachusetts, Forenede Stater, 02135-2997
    - Caritas St. Elizabeth's Medical Center
  - Gloucester, Massachusetts, Forenede Stater, 01930
    - Addison Gilbert Hospital
  - Milford, Massachusetts, Forenede Stater, 01757
    - Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
  - South Weymouth, Massachusetts, Forenede Stater, 02190
    - Dana-Farber/Brigham and Women's Cancer Center at South Shore
- Michigan
  - Adrian, Michigan, Forenede Stater, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Adrian, Michigan, Forenede Stater, 49221
    - Toledo Clinic Cancer Centers - Adrian
  - Ann Arbor, Michigan, Forenede Stater, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Battle Creek, Michigan, Forenede Stater, 49017
    - Battle Creek Health System Cancer Care Center
  - Big Rapids, Michigan, Forenede Stater, 49307
    - Mecosta County Medical Center
  - Dearborn, Michigan, Forenede Stater, 48124
    - Oakwood Hospital
  - Dearborn, Michigan, Forenede Stater, 48124
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Detroit, Michigan, Forenede Stater, 48236
    - Saint John Hospital and Medical Center
  - Escanaba, Michigan, Forenede Stater, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, Forenede Stater, 48503
    - Hurley Medical Center
  - Flint, Michigan, Forenede Stater, 48503
    - Genesys Hurley Cancer Institute
  - Grand Blanc, Michigan, Forenede Stater, 48439
    - Genesys Regional Medical Center
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Butterworth Hospital at Spectrum Health
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grosse Pointe Woods, Michigan, Forenede Stater, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, Forenede Stater, 49801
    - Dickinson County Healthcare System
  - Iron Mountain, Michigan, Forenede Stater, 49801
    - Green Bay Oncology - Iron Mountain
  - Jackson, Michigan, Forenede Stater, 49201
    - Allegiance Health
  - Jackson, Michigan, Forenede Stater, 49201
    - Foote Memorial Hospital
  - Kalamazoo, Michigan, Forenede Stater, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, Forenede Stater, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, Forenede Stater, 49007-3731
    - West Michigan Cancer Center
  - Lansing, Michigan, Forenede Stater, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, Forenede Stater, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, Forenede Stater, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, Forenede Stater, 48162
    - Mercy Memorial Hospital - Monroe
  - Monroe, Michigan, Forenede Stater, 48162
    - Toledo Clinic Cancer Centers - Monroe
  - Muskegon, Michigan, Forenede Stater, 49444
    - Mercy General Health Partners
  - Pontiac, Michigan, Forenede Stater, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, Forenede Stater, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Reed City, Michigan, Forenede Stater, 49677
    - Spectrum Health Reed City Hospital
  - Saginaw, Michigan, Forenede Stater, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Southfield, Michigan, Forenede Stater, 48075
    - Providence Cancer Institute at Providence Hospital - Southfield Campus
  - Traverse City, Michigan, Forenede Stater, 49684
    - Munson Medical Center
  - Warren, Michigan, Forenede Stater, 48093
    - St. John Macomb Hospital
- Minnesota
  - Bemidji, Minnesota, Forenede Stater, 56601
    - Sanford Clinic North-Bemidji
  - Brainerd, Minnesota, Forenede Stater, 56401
    - St. Joseph's Medical Center
  - Burnsville, Minnesota, Forenede Stater, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, Forenede Stater, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, Forenede Stater, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, Forenede Stater, 55805
    - Miller - Dwan Medical Center
  - Duluth, Minnesota, Forenede Stater, 55805-1983
    - Essentia Health - Duluth Clinic
  - Edina, Minnesota, Forenede Stater, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, Forenede Stater, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, Forenede Stater, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, Forenede Stater, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Maplewood, Minnesota, Forenede Stater, 55109
    - Minnesota Oncology - Maplewood
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55455
    - Masonic Cancer Center at University of Minnesota
  - Minneapolis, Minnesota, Forenede Stater, 55415
    - Hennepin County Medical Center - Minneapolis
  - New Ulm, Minnesota, Forenede Stater, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, Forenede Stater, 55422-2900
    - Humphrey Cancer Center at North Memorial Outpatient Center
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, Forenede Stater, 55102
    - United Hospital
  - Saint Paul, Minnesota, Forenede Stater, 55101
    - Regions Hospital Cancer Care Center
  - Shakopee, Minnesota, Forenede Stater, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - Stillwater, Minnesota, Forenede Stater, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, Forenede Stater, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, Forenede Stater, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, Forenede Stater, 55125
    - Minnesota Oncology - Woodbury
- Mississippi
  - Jackson, Mississippi, Forenede Stater, 39216
    - University of Mississippi Cancer Clinic
  - Pascagoula, Mississippi, Forenede Stater, 39581
    - Regional Cancer Center at Singing River Hospital
- Missouri
  - Bolivar, Missouri, Forenede Stater, 65613
    - Central Care Cancer Center at Carrie J. Babb Cancer Center
  - Branson, Missouri, Forenede Stater, 65616
    - Cox Cancer Center Branson
  - Branson, Missouri, Forenede Stater, 65616
    - Skaggs Cancer Center at Skaggs Regional Medical Center
  - Cape Girardeau, Missouri, Forenede Stater, 63703
    - Southeast Cancer Center
  - Columbia, Missouri, Forenede Stater, 65203
    - Ellis Fischel Cancer Center at University of Missouri - Columbia
  - Columbia, Missouri, Forenede Stater, 65201
    - Veterans Administration/Harry S Truman Memorial Hospital
  - Jefferson City, Missouri, Forenede Stater, 65109
    - Goldschmidt Cancer Center
  - Saint Louis, Missouri, Forenede Stater, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, Forenede Stater, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, Forenede Stater, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  - Springfield, Missouri, Forenede Stater, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, Forenede Stater, 65807
    - Hulston Cancer Center at Cox Medical Center South
  - Springfield, Missouri, Forenede Stater, 65804
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, Forenede Stater, 65804
    - Mercy-Springfield
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, Forenede Stater, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, Forenede Stater, 59107-7000
    - Billings Clinic - Downtown
  - Billings, Montana, Forenede Stater, 59102
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Bozeman, Montana, Forenede Stater, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, Forenede Stater, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, Forenede Stater, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, Forenede Stater, 59405-5309
    - Big Sky Oncology
  - Great Falls, Montana, Forenede Stater, 59405
    - Benefis Sletten Cancer Institute
  - Helena, Montana, Forenede Stater, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, Forenede Stater, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, Forenede Stater, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, Forenede Stater, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Kearney, Nebraska, Forenede Stater, 68848-1990
    - Good Samaritan Cancer Center at Good Samaritan Hospital
- Nevada
  - Reno, Nevada, Forenede Stater, 89502
    - Renown Institute for Cancer at Renown Regional Medical Center
- New Hampshire
  - Concord, New Hampshire, Forenede Stater, 03301
    - New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
  - Exeter, New Hampshire, Forenede Stater, 03833
    - Center for Cancer Care at Exeter Hospital
  - Hooksett, New Hampshire, Forenede Stater, 03106
    - New Hampshire Oncology - Hematology, PA - Hooksett
  - Laconia, New Hampshire, Forenede Stater, 03246
    - Lakes Region General Hospital
  - Lebanon, New Hampshire, Forenede Stater, 03756-0002
    - Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  - Londonderry, New Hampshire, Forenede Stater, 03053
    - Dana-Farber Cancer Institute at Londonderry
  - Manchester, New Hampshire, Forenede Stater, 03102
    - Norris Cotton Cancer Center-Manchester
- New Jersey
  - Camden, New Jersey, Forenede Stater, 08103
    - Cooper Hospital University Medical Center
  - East Orange, New Jersey, Forenede Stater, 07018
    - Veterans Administration New Jersey Health Care System
  - Newark, New Jersey, Forenede Stater, 07112
    - Newark Beth Israel Medical Center
  - Ridgewood, New Jersey, Forenede Stater, 07450
    - Valley Hospital - Ridgewood
  - Voorhees, New Jersey, Forenede Stater, 08043
    - Cancer Institute of New Jersey at Cooper - Voorhees
- New York
  - Brooklyn, New York, Forenede Stater, 11209
    - Veterans Affairs Medical Center - Brooklyn
  - Buffalo, New York, Forenede Stater, 14215
    - Veterans Affairs Medical Center - Buffalo
  - East Syracuse, New York, Forenede Stater, 13057
    - CCOP - Hematology-Oncology Associates of Central New York
  - Glens Falls, New York, Forenede Stater, 12801
    - Charles R. Wood Cancer Center at Glens Falls Hospital
  - Lake Success, New York, Forenede Stater, 11042
    - Monter Cancer Center of the North Shore-LIJ Health System
  - Manhasset, New York, Forenede Stater, 11030
    - CCOP - North Shore University Hospital
  - Manhasset, New York, Forenede Stater, 11030
    - Don Monti Comprehensive Cancer Center at North Shore University Hospital
  - Middletown, New York, Forenede Stater, 10940
    - Orange Regional Medical Center
  - New Hyde Park, New York, Forenede Stater, 11040
    - Long Island Jewish Medical Center
  - New York, New York, Forenede Stater, 10021
    - New York Weill Cornell Cancer Center at Cornell University
  - Rochester, New York, Forenede Stater, 14621
    - Lipson Cancer and Blood Center at Rochester General Hospital
  - Syracuse, New York, Forenede Stater, 13210
    - Veterans Affairs Medical Center - Syracuse
  - Syracuse, New York, Forenede Stater, 13210
    - SUNY Upstate Medical University Hospital
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28801
    - Mission Hospitals - Memorial Campus
  - Durham, North Carolina, Forenede Stater, 27705
    - Veterans Affairs Medical Center - Durham
  - Durham, North Carolina, Forenede Stater, 27710
    - Duke Cancer Institute
  - Goldsboro, North Carolina, Forenede Stater, 27534
    - Wayne Memorial Hospital, Incorporated
  - Kinston, North Carolina, Forenede Stater, 28501
    - Kinston Medical Specialists
  - Lumberton, North Carolina, Forenede Stater, 28359
    - Southeastern Regional Medical Center
  - Oxford, North Carolina, Forenede Stater, 27565
    - Granville Medical Center
  - Pinehurst, North Carolina, Forenede Stater, 28374
    - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
  - Raleigh, North Carolina, Forenede Stater, 27609
    - Duke Health Raleigh Hospital
  - Roxboro, North Carolina, Forenede Stater, 27573
    - Person Memorial Hospital
  - Statesville, North Carolina, Forenede Stater, 28677
    - Iredell Memorial Hospital
  - Washington, North Carolina, Forenede Stater, 27889
    - Marion L. Shepard Cancer Center at Beaufort County Hospital
- North Dakota
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Sanford Bismarck Medical Center
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, Forenede Stater, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, Forenede Stater, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, Forenede Stater, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Fargo, North Dakota, Forenede Stater, 58122
    - Sanford Clinic North-Fargo
  - Fargo, North Dakota, Forenede Stater, 58102
    - Sanford Clinic North-Fargo
  - Fargo, North Dakota, Forenede Stater, 58103
    - Dakota Cancer Institute at Dakota Clinic - South University
  - Grand Forks, North Dakota, Forenede Stater, 58201
    - Altru Cancer Center at Altru Hospital
  - Minot, North Dakota, Forenede Stater, 58701
    - Trinity Cancercare Center
- Ohio
  - Bowling Green, Ohio, Forenede Stater, 43402
    - Wood County Oncology Center
  - Cincinnati, Ohio, Forenede Stater, 45267
    - Charles M. Barrett Cancer Center at University Hospital
  - Columbus, Ohio, Forenede Stater, 43210-1240
    - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
  - Dayton, Ohio, Forenede Stater, 45405
    - Grandview Hospital
  - Dayton, Ohio, Forenede Stater, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, Forenede Stater, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, Forenede Stater, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, Forenede Stater, 45420
    - Dayton CCOP
  - Dayton, Ohio, Forenede Stater, 45420
    - CCOP - Dayton
  - Elyria, Ohio, Forenede Stater, 44035
    - Community Cancer Center
  - Elyria, Ohio, Forenede Stater, 44035
    - Hematology Oncology Center
  - Findlay, Ohio, Forenede Stater, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, Forenede Stater, 45005-1066
    - Middletown Regional Hospital
  - Greenville, Ohio, Forenede Stater, 45331
    - Wayne Hospital
  - Kettering, Ohio, Forenede Stater, 45429
    - Charles F. Kettering Memorial Hospital
  - Lima, Ohio, Forenede Stater, 45804
    - Lima Memorial Hospital
  - Lima, Ohio, Forenede Stater, 45801
    - St. Rita's Medical Center
  - Maumee, Ohio, Forenede Stater, 43537-1839
    - Northwest Ohio Oncology Center
  - Maumee, Ohio, Forenede Stater, 43537
    - Toledo Clinic Cancers Centers - Maumee
  - Oregon, Ohio, Forenede Stater, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, Forenede Stater, 43616
    - Toledo Clinic - Oregon
  - Sylvania, Ohio, Forenede Stater, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, Forenede Stater, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, Forenede Stater, 43614
    - University of Toledo
  - Toledo, Ohio, Forenede Stater, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, Forenede Stater, 43606
    - Toledo Hospital
  - Toledo, Ohio, Forenede Stater, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, Forenede Stater, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, Forenede Stater, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, Forenede Stater, 43623
    - St. Anne Mercy Hospital
  - Troy, Ohio, Forenede Stater, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, Forenede Stater, 43567
    - Fulton County Health Center
  - Xenia, Ohio, Forenede Stater, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Oklahoma
  - Lawton, Oklahoma, Forenede Stater, 73505
    - Cancer Centers of Southwest Oklahoma, LLC - Lawton
  - Norman, Oklahoma, Forenede Stater, 73071
    - Mercy Clinic Oklahoma Communities Inc-Norman
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - Oklahoma University Cancer Institute
  - Oklahoma City, Oklahoma, Forenede Stater, 73120
    - Mercy Clinic Oklahoma Communities Inc-Mercy Health Center
- Oregon
  - The Dalles, Oregon, Forenede Stater, 97058
    - Celilo Cancer Center at Mid-Columbia Medical Center
- Pennsylvania
  - Abington, Pennsylvania, Forenede Stater, 19001
    - Rosenfeld Cancer Center at Abington Memorial Hospital
- Rhode Island
  - Providence, Rhode Island, Forenede Stater, 02906
    - Miriam Hospital
  - Providence, Rhode Island, Forenede Stater, 02903
    - Rhode Island Hospital Comprehensive Cancer Center
- South Carolina
  - Florence, South Carolina, Forenede Stater, 29501
    - McLeod Regional Medical Center
- South Dakota
  - Rapid City, South Dakota, Forenede Stater, 57701
    - Rapid City Regional Hospital
- Tennessee
  - Kingsport, Tennessee, Forenede Stater, 37662
    - Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Vermont
  - White River Junction, Vermont, Forenede Stater, 05009
    - Veterans Affairs Medical Center - White River Junction
  - White River Junction, Vermont, Forenede Stater, 05009
    - White River Junction Veteran Administration Medical Center
- Virginia
  - Danville, Virginia, Forenede Stater, 24541
    - Danville Regional Medical Center
  - Fredericksburg, Virginia, Forenede Stater, 22401
    - Fredericksburg Oncology, Incorporated
  - Lynchburg, Virginia, Forenede Stater, 24501
    - Lynchburg Hematology-Oncology Clinic
  - Martinsville, Virginia, Forenede Stater, 24115
    - Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
  - Norton, Virginia, Forenede Stater, 24273
    - Southwest Virginia Regional Cancer Center at Wellmonth Health
- Washington
  - Anacortes, Washington, Forenede Stater, 98221
    - Island Hospital Cancer Care Center at Island Hospital
  - Auburn, Washington, Forenede Stater, 98002
    - Auburn Regional Center for Cancer Care
  - Bellevue, Washington, Forenede Stater, 98004
    - Overlake Cancer Center at Overlake Hospital Medical Center
  - Bellingham, Washington, Forenede Stater, 98225
    - St. Joseph Cancer Center
  - Bremerton, Washington, Forenede Stater, 98310
    - Olympic Hematology and Oncology
  - Burien, Washington, Forenede Stater, 98166
    - Highline Medical Center Cancer Center
  - Centralia, Washington, Forenede Stater, 98531
    - Providence Centralia Hospital
  - Edmonds, Washington, Forenede Stater, 98026
    - Swedish Medical Center-Edmonds
  - Everett, Washington, Forenede Stater, 98201
    - Providence Regional Cancer Partnership
  - Federal Way, Washington, Forenede Stater, 98003
    - Saint Francis Hospital
  - Issaquah, Washington, Forenede Stater, 98029
    - Swedish Medical Center - Issaquah Campus
  - Kennewick, Washington, Forenede Stater, 99336
    - Columbia Basin Hematology
  - Mount Vernon, Washington, Forenede Stater, 98274
    - Skagit Valley Hospital Cancer Care Center
  - Olympia, Washington, Forenede Stater, 98506-5166
    - Providence St. Peter Hospital Regional Cancer Center
  - Poulsbo, Washington, Forenede Stater, 98370
    - Harrison Poulsbo Hematology and Onocology
  - Puyallup, Washington, Forenede Stater, 98372
    - Good Samaritan Cancer Center
  - Seattle, Washington, Forenede Stater, 98109
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, Forenede Stater, 98104
    - Harborview Medical Center
  - Seattle, Washington, Forenede Stater, 98112
    - Group Health Central Hospital
  - Seattle, Washington, Forenede Stater, 98122-4307
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Seattle, Washington, Forenede Stater, 98195
    - University Cancer Center at University of Washington Medical Center
  - Sedro-Woolley, Washington, Forenede Stater, 98284
    - North Puget Oncology at United General Hospital
  - Spokane, Washington, Forenede Stater, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, Forenede Stater, 99218
    - Evergreen Hematology and Oncology, PS
  - Tacoma, Washington, Forenede Stater, 98405
    - Saint Joseph Medical Center
  - Tacoma, Washington, Forenede Stater, 98405
    - Allenmore Hospital
  - Tacoma, Washington, Forenede Stater, 98405
    - Northwest CCOP
  - Tacoma, Washington, Forenede Stater, 98499
    - Saint Clare Hospital
  - Tacoma, Washington, Forenede Stater, 98415
    - Multicare Health System - Tacoma General Hospital
  - Wenatchee, Washington, Forenede Stater, 98801-2028
    - Wenatchee Valley Medical Center
- West Virginia
  - Huntington, West Virginia, Forenede Stater, 25701
    - Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
  - Morgantown, West Virginia, Forenede Stater, 26506
    - Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- Wisconsin
  - Chippewa Falls, Wisconsin, Forenede Stater, 54729
    - Marshfield Clinic - Chippewa Center
  - Eau Claire, Wisconsin, Forenede Stater, 54701
    - Marshfield Clinic Cancer Care at Regional Cancer Center
  - Green Bay, Wisconsin, Forenede Stater, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, Forenede Stater, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, Forenede Stater, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, Forenede Stater, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Janesville, Wisconsin, Forenede Stater, 53547
    - Mercy Regional Cancer Center
  - La Crosse, Wisconsin, Forenede Stater, 54601
    - Gundersen Lutheran Center for Cancer and Blood
  - Manitowoc, Wisconsin, Forenede Stater, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Marinette, Wisconsin, Forenede Stater, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Marshfield, Wisconsin, Forenede Stater, 54449
    - Marshfield Clinic - Marshfield Center
  - Minocqua, Wisconsin, Forenede Stater, 54548
    - Marshfield Clinic - Minocqua Center
  - Mukwonago, Wisconsin, Forenede Stater, 53149
    - D.N. Greenwald Center
  - New Richmond, Wisconsin, Forenede Stater, 54017
    - Westfields Hospital/Cancer Center of Western Wisconsin
  - Oconomowoc, Wisconsin, Forenede Stater, 53066
    - Regional Cancer Center at Oconomowoc Memorial Hospital
  - Oconto Falls, Wisconsin, Forenede Stater, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Rhinelander, Wisconsin, Forenede Stater, 54501
    - Marshfield Clinic at James Beck Cancer Center
  - Rhinelander, Wisconsin, Forenede Stater, 54501
    - Ministry Medical Group at Saint Mary's Hospital
  - Rice Lake, Wisconsin, Forenede Stater, 54868
    - Marshfield Clinic - Rice Lake Center
  - Sheboygan, Wisconsin, Forenede Stater, 53081
    - St. Nicholas Hospital
  - Stevens Point, Wisconsin, Forenede Stater, 54481
    - Marshfield Clinic at Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, Forenede Stater, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
  - Waukesha, Wisconsin, Forenede Stater, 53188
    - Waukesha Memorial Hospital Regional Cancer Center
  - Weston, Wisconsin, Forenede Stater, 54476
    - Diagnostic and Treatment Center
  - Weston, Wisconsin, Forenede Stater, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Casper, Wyoming, Forenede Stater, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, Forenede Stater, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Arm I 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.	Medicin: gemcitabin hydrochlorid Givet IV Medicin: carboplatin Givet IV Medicin: pemetrexed dinatrium Givet IV Medicin: celecoxib Gives oralt
Aktiv komparator: Arm II Patients receive gemcitabine hydrochloride* OR pemetrexed disodium* and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 1-21.	Andet: placebo Gives oralt Medicin: gemcitabin hydrochlorid Givet IV Medicin: carboplatin Givet IV Medicin: pemetrexed dinatrium Givet IV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Progression-free Survival Tidsramme: Time between randomization and disease relapse or death from any cause, assessed up to 5 years	Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.	Time between randomization and disease relapse or death from any cause, assessed up to 5 years

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Overall Survival Tidsramme: Time between randomization and death from any cause, assessed up to 5 years	Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.	Time between randomization and death from any cause, assessed up to 5 years
Response Rate Tidsramme: Up to 5 years	The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test	Up to 5 years
Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0 Tidsramme: Up to 5 years	The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment	Up to 5 years
Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1) Tidsramme: Up to 5 years	Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the first quartile (Q1, 10.09). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.	Up to 5 years
Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2) Tidsramme: Up to 5 years	prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q2, 15.38). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.	Up to 5 years
Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Third Quartile (Q3) Tidsramme: Up to 5 years	Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q3, 27.86). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.	Up to 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

Studiestol: Martin J. Edelman, MD, University of Maryland Greenebaum Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2010

Primær færdiggørelse (Faktiske)

17. januar 2017

Studieafslutning (Faktiske)

1. marts 2018

Datoer for studieregistrering

Først indsendt

31. december 2009

Først indsendt, der opfyldte QC-kriterier

31. december 2009

Først opslået (Skøn)

1. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CALGB-30801
CDR0000662707 (Registry Identifier: NCI Physician Data Query)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lungekræft

Seoul National University Hospital

Afsluttet

Effektiviteten af Lung Sono i One-lung Ventilation

One Lung Ventilation

Korea, Republikken
Seoul National University Hospital

Afsluttet

Forkonditionering af One-lung Ventilation

One Lung Ventilation

Korea, Republikken
Chinese Chronic Respiratory Disease Research Network

Rekruttering

Kohorteundersøgelse af lungeknudeintervention (LNICS)

Hændelse Lung Nodule

Kina
Mansoura University

Afsluttet

Sammenligning af tre metoder til PEEP-titrering under én lungeventilation i liggende stilling

One Lung Ventilation

Egypten
Dokuz Eylul University

Afsluttet

Evaluering af en lungeventilation med ultralyd ved thoraxkirurgiske operationer

One Lung Ventilation

Kalkun
Yonsei University

Afsluttet

Positivt endeekspiratorisk tryk og alveolær rekruttering til én lungeventilation

One Lung Ventilation

Korea, Republikken
Sichuan University
West China Hospital

Midlertidigt ikke tilgængelig

Ændringen af pulmonal blodgennemstrømning under én lungeventilation

One Lung Ventilation
Luca Brazzi
A.O.U. Città della Salute e della Scienza - Molinette Hospital

Ikke rekrutterer endnu

Videolaryngoskopi vs direkte laryngoskopi til placering af lumenrør med dobbelt lumen - Et multicenter randomiseret-kontrolleret forsøg (VOLCANO-undersøgelse) (VOLCANO)

Intubationskomplikation | One Lung Ventilation
Ankara Ataturk Sanatorium Training and Research...

Ikke rekrutterer endnu

Korrelation mellem iltnings- og mætningsindekser i enlungeventilation (OLV-INDICES)

One-lung Ventilation (OLV)

Tyrkiet (Türkiye)
Joseph D. Tobias

Afsluttet

Intracuff-tryk under en-lungeventilation hos spædbørn og børn

One-lung Ventilation (OLV)

Forenede Stater

Kliniske forsøg med placebo

Galderma R&D

Afsluttet

Effekt af CD07805/47 Gel i Rosacea Flushing

Rosacea

Tyskland
SamA Pharmaceutical Co., Ltd

Ukendt

Kliniske forsøg for at vurdere effektiviteten og sikkerheden af HLIM

Akut bronkitis | Akut øvre luftvejsinfektion

Korea, Republikken
National Institute on Drug Abuse (NIDA)

Afsluttet

Virkninger af cannabisadministrationsveje på menneskelig ydeevne og farmakokinetik

Brug af cannabis

Forenede Stater
Akeso

Ikke rekrutterer endnu

En klinisk undersøgelse af AK120 hos unge med moderat til svær atopisk dermatitis

Atopisk dermatitis

Kina
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Afsluttet

Vurdering af sikkerhed, tolerabilitet og farmakodynamik efter administration af én dosis AZD8601 til mandlige patienter med type II diabetes mellitus (T2DM)

Mandlige forsøgspersoner med type II-diabetes (T2DM)

Tyskland
Heptares Therapeutics Limited

Afsluttet

Farmakokinetik af oral kapsel hos raske japanske vs. kaukasiske forsøgspersoner (HTL0018318)

Farmakokinetik | Sikkerhedsproblemer

Det Forenede Kongerige
Cellmedis
Medical Network Sp. z o.o.

Ikke rekrutterer endnu

New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease: rEsults oF a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Trial. (The RELIEF Trial) (RELIEF)

GERD (gastroøsofageal reflukssygdom) | NERD

Polen
Texas A&M University
Nutrabolt

Afsluttet

Glycemic Response of a Commercial Food Bar (NB16)

Glukose og insulinrespons
Regado Biosciences, Inc.

Afsluttet

Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD (SC101)

Sund frivillig

Forenede Stater
LifeMine Therapeutics

Rekruttering

En fase I-undersøgelse for at evaluere Life-001

Sunde frivillige

Australien

Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer

A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Lungekræft

Kliniske forsøg med placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Austria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer