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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 giugno 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Cancro ai polmoni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

313

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Doppio

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: 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.	Droga: gemcitabina cloridrato Dato IV Droga: carboplatino Dato IV Droga: pemetrexed disodico Dato IV Droga: celecoxib Dato oralmente
Comparatore attivo: 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.	Altro: placebo Dato oralmente Droga: gemcitabina cloridrato Dato IV Droga: carboplatino Dato IV Droga: pemetrexed disodico Dato IV

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Progression-free Survival Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Overall Survival Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

Cattedra di studio: Martin J. Edelman, MD, University of Maryland Greenebaum Cancer Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2010

Completamento primario (Effettivo)

17 gennaio 2017

Completamento dello studio (Effettivo)

1 marzo 2018

Date di iscrizione allo studio

Primo inviato

31 dicembre 2009

Primo inviato che soddisfa i criteri di controllo qualità

31 dicembre 2009

Primo Inserito (Stima)

1 gennaio 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2018

Ultimo verificato

1 giugno 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

CALGB-30801
CDR0000662707 (Identificatore di registro: NCI Physician Data Query)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cancro ai polmoni

National Cancer Institute (NCI)

Terminato

Terapia genica del recettore delle cellule T mirata a KK-LC-1 per tumori epiteliali gastrici, mammari, cervicali, polmonari e altri positivi a KK-LC-1

Kita-kyushu Lung Cancer Antigen 1, umano

Stati Uniti
Zeba Ahmad, Ph.D.
American Cancer Society, Inc.

Reclutamento

Adattare l'intervento di resilienza psicosociale per i genitori di adolescenti e giovani adulti con cancro (RAISE)

Caregiving for Cancer

Stati Uniti
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Completato

Bevacizumab, capecitabina e oxaliplatino nel trattamento dell'intestino tenue avanzato o dell'ampolla dell'adenocarcinoma di Vater

Adenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioni

Stati Uniti
Georgetown University
National Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...

Completato

Donne cinesi e screening mammografico

Studio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer Society

Stati Uniti
Institut Cancerologie de l'Ouest

Attivo, non reclutante

Valutazione dell'efficienza del massaggio touch sulla qualità della vita al lavoro del personale infermieristico che lavora in un centro per il cancro. (Pausa "Massage toucher (TM)") (PauseTM)

Qualità della vita al lavoro | Professionisti paramedici | Toccare Massaggio | Cancer Center

Francia
Emory University
National Cancer Institute (NCI)

Ritirato

Radiochirurgia stereotassica con Abemaciclib, Ribociclib o Palbociclib nel trattamento di pazienti con carcinoma mammario positivo ai recettori ormonali con metastasi cerebrali

Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
Yonsei University

Non ancora reclutamento

Uno studio di fase II multicentrico a braccio aperto, singolo per valutare l'efficacia di amivantamab in combinazione con FOLFIRI come trattamento di seconda linea in pazienti con carcinoma del colon-retto avanzato di tipo selvaggio RAS/BRAF che progredisce su un precedente trattamento anti-EGFR.

RAS/BRAF Wild-Type Advanced Cancer Mathement

Corea, Repubblica di
NRG Oncology
National Cancer Institute (NCI)

Completato

Testare se il trattamento delle metastasi del cancro al seno con la chirurgia o le radiazioni ad alte dosi migliora la sopravvivenza

Cancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioni

Stati Uniti, Canada, Arabia Saudita, Corea del Sud
Jonsson Comprehensive Cancer Center

Reclutamento

Terapia Focale con Radiazioni (HDR-Brachyterapia) per il Trattamento del Cancro alla Prostata

Adenocarcinoma prostatico | Cancro alla prostata in stadio II AJCC v8 | Fase I Cancro alla prostata American Joint Committee on Cancer (AJCC) v8

Stati Uniti
Jonsson Comprehensive Cancer Center
Novartis Pharmaceuticals

Reclutamento

Valutazione di un programma di dosaggio flessibile di 177Lu-PSMA-617 per il trattamento del cancro alla prostata metastatico resistente alla castrazione

Carcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8

Stati Uniti

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

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tipo di studio

Iscrizione (Effettivo)

Fase

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

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Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

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Investigatori

Pubblicazioni e link utili

Pubblicazioni generali

Studiare le date dei record

Studia le date principali

Inizio studio

Completamento primario (Effettivo)

Completamento dello studio (Effettivo)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Stima)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Prove cliniche su Cancro ai polmoni

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Jordan

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi