AzTrials
AzTrials

Lung CancerPhase 3NCT01041781

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

A Phase 3 study testing carboplatin, celecoxib and gemcitabine hydrochloride in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 400 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, celecoxib and gemcitabine hydrochloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
313 participants
Where
400 sitesUnited States
Study dates
Feb 2010to Mar 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

400 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Toledo Clinic Cancer Centers - Adrian

    Adrian, Michigan, 49221

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Island Hospital Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Regional Medical Center

    Anniston, Alabama, 36207

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Veterans Affairs Medical Center - Baltimore

    Baltimore, Maryland, 21201

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • CancerCare of Maine at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Overlake Cancer Center at Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Sanford Clinic North-Bemidji

    Bemidji, Minnesota, 56601

  • National Naval Medical Center

    Bethesda, Maryland, 20889-5600

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Central Care Cancer Center at Carrie J. Babb Cancer Center

    Bolivar, Missouri, 65613

  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • St. Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Skaggs Cancer Center at Skaggs Regional Medical Center

    Branson, Missouri, 65616

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Caritas St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135-2997

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York, 11209

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Highline Medical Center Cancer Center

    Burien, Washington, 98166

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Helen G Nassif Community Cancer Center

    Cedar Rapids, Iowa, 52402

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa, 52402

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Providence Centralia Hospital

    Centralia, Washington, 98531

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Marshfield Clinic - Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Medical Oncology and Hematology Associates - West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center - West Lakes

    Clive, Iowa, 50325

  • Veterans Administration/Harry S Truman Memorial Hospital

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

    Concord, New Hampshire, 03301

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Dayton CCOP

    Dayton, Ohio, 45420

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • Oakwood Hospital

    Dearborn, Michigan, 48124

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • North Broward Medical Center

    Deerfield Beach, Florida, 33064-3596

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Essentia Health - Duluth Clinic

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • Veterans Administration New Jersey Health Care System

    East Orange, New Jersey, 07018

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Medical Center-Edmonds

    Edmonds, Washington, 98026

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Community Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • Evanston Hospital

    Evanston, Illinois, 60201-1781

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Center for Cancer Care at Exeter Hospital

    Exeter, New Hampshire, 03833

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58102

  • Dakota Cancer Institute at Dakota Clinic - South University

    Fargo, North Dakota, 58103

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • John R. Marsh Cancer Center at Washington County Hospital

    Hagerstown, Maryland, 21740

  • Meritus Medical Center

    Hagerstown, Maryland, 21742

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Oncare Hawaii Inc-POB II

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817-3169

  • Hawaii Medical Center - East

    Honolulu, Hawaii, 96817

  • OnCare Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • New Hampshire Oncology - Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital

    Huntington, West Virginia, 25701

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • St. Francis Hospital Cancer Care Services

    Indianapolis, Indiana, 46237

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Veterans Affairs Medical Center - Iowa City

    Iowa City, Iowa, 52246

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Swedish Medical Center - Issaquah Campus

    Issaquah, Washington, 98029

  • Allegiance Health

    Jackson, Michigan, 49201

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Mercy Regional Cancer Center

    Janesville, Wisconsin, 53547

  • Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • NEA Medical Clinic - East Matthews

    Jonesboro, Arkansas, 72401

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Illinois CancerCare - Kewanee Clinic

    Kewanee, Illinois, 61443

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Monter Cancer Center of the North Shore-LIJ Health System

    Lake Success, New York, 11042

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Cancer Centers of Southwest Oklahoma, LLC - Lawton

    Lawton, Oklahoma, 73505

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Saint Joseph Regional Medical Center

    Lewiston, Idaho, 83501

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Dana-Farber Cancer Institute at Londonderry

    Londonderry, New Hampshire, 03053

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Southeastern Regional Medical Center

    Lumberton, North Carolina, 28359

  • Lynchburg Hematology-Oncology Clinic

    Lynchburg, Virginia, 24501

  • Illinois CancerCare - Macomb

    Macomb, Illinois, 61455

  • Norris Cotton Cancer Center-Manchester

    Manchester, New Hampshire, 03102

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Don Monti Comprehensive Cancer Center at North Shore University Hospital

    Manhasset, New York, 11030

  • Holy Family Memorial Medical Center Cancer Care Center

    Manitowoc, Wisconsin, 54221-1450

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology - Maplewood

    Maplewood, Minnesota, 55109

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

    Martinsville, Virginia, 24115

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • Toledo Clinic Cancers Centers - Maumee

    Maumee, Ohio, 43537

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Middlesex Hospital Cancer Center

    Middletown, Connecticut, 06457

  • Orange Regional Medical Center

    Middletown, New York, 10940

  • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center

    Milford, Massachusetts, 01757

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota, 55455

  • Marshfield Clinic - Minocqua Center

    Minocqua, Wisconsin, 54548

  • Trinity CancerCare Center

    Minot, North Dakota, 58701

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Garneau, Stewart C MD (UIA Investigator)

    Moline, Illinois, 61265

  • Porubcin, Michael (UIA Investigator)

    Moline, Illinois, 61265

  • Spector, David MD (UIA Investigator)

    Moline, Illinois, 61265

  • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

    Moline, Illinois, 61265

  • Illinois CancerCare - Monmouth

    Monmouth, Illinois, 61462

  • OSF Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Louisiana State University Health Sciences Center - Monroe

    Monroe, Louisiana, 71210

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Toledo Clinic Cancer Centers - Monroe

    Monroe, Michigan, 48162

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98274

  • Camino Medical Group - Treatment Center

    Mountain View, California, 94040

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

  • D.N. Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Mercy General Health Partners

    Muskegon, Michigan, 49444

  • Hematology Oncology Consultants - Naperville

    Naperville, Illinois, 60540

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Interim LSU Public Hospital

    New Orleans, Louisiana, 70112

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

  • Westfields Hospital/Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Illinois CancerCare - Community Cancer Center

    Normal, Illinois, 61761

  • Mercy Clinic Oklahoma Communities Inc-Norman

    Norman, Oklahoma, 73071

  • Southwest Virginia Regional Cancer Center at Wellmonth Health

    Norton, Virginia, 24273

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

  • Regional Cancer Center at Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Mercy Clinic Oklahoma Communities Inc-Mercy Health Center

    Oklahoma City, Oklahoma, 73120

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Florida Hospital - Orlando

    Orlando, Florida, 32803

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • McCreery Cancer Center at Ottumwa Regional

    Ottumwa, Iowa, 52501

  • Granville Medical Center

    Oxford, North Carolina, 27565

  • Palo Alto Medical Foundation

    Palo Alto, California, 94301

  • Feather River Hospital Cancer Center

    Paradise, California, 95969

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Illinois CancerCare - Pekin

    Pekin, Illinois, 61603

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare - Peru

    Peru, Illinois, 61354

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina, 28374

  • PCR Oncology

    Pismo Beach, California, 93449

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Lung Cancer
Being tested
carboplatin, celecoxib, gemcitabine hydrochloride, pemetrexed disodium, placebo
Keywords
adenocarcinoma of the lung, adenosquamous cell lung cancer, large cell lung cancer, squamous cell lung cancer, recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01041781
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Drug: carboplatin; Drug: celecoxib; Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium
Arm IIActive comparatorPatients receive gemcitabine hydrochloride* OR pemetrexed disodium* and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 1-21.
Receives: Drug: carboplatin; Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium; Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

    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.

    Measured: Time between randomization and disease relapse or death from any cause, assessed up to 5 years

Secondary outcomes (6)

  1. Overall Survival

    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.

    Measured: Time between randomization and death from any cause, assessed up to 5 years

  2. Response Rate

    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

    Measured: Up to 5 years

  3. Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0

    The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment

    Measured: Up to 5 years

  4. 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)

    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.

    Measured: Up to 5 years

  5. 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)

    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.

    Measured: Up to 5 years

  6. 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)

    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.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completion17 Jan 2017
  4. Study completionMar 2018

Why it stopped: DSMB recommendation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01041781
Sponsor's protocol ID
CALGB-30801
Other IDs
CALGB-30801, CDR0000662707
Status last verified
Jun 2018
First submitted
31 Dec 2009
Last updated
23 Jul 2018
Data monitoring committee
Yes

Publications

  • Edelman MJ, Wang X, Hodgson L, Cheney RT, Baggstrom MQ, Thomas SP, Gajra A, Bertino E, Reckamp KL, Molina J, Schiller JH, Mitchell-Richards K, Friedman PN, Ritter J, Milne G, Hahn OM, Stinchcombe TE, Vokes EE; Alliance for Clinical Trials in Oncology. Phase III Randomized, Placebo-Controlled, Double-Blind Trial of Celecoxib in Addition to Standard Chemotherapy for Advanced Non-Small-Cell Lung Cancer With Cyclooxygenase-2 Overexpression: CALGB 30801 (Alliance). J Clin Oncol. 2017 Jul 1;35(19):2184-2192. doi: 10.1200/JCO.2016.71.3743. Epub 2017 May 10.

    PubMed 28489511

  • Hamy AS, Tury S, Wang X, Gao J, Pierga JY, Giacchetti S, Brain E, Pistilli B, Marty M, Espie M, Benchimol G, Laas E, Lae M, Asselain B, Aouchiche B, Edelman M, Reyal F. Celecoxib With Neoadjuvant Chemotherapy for Breast Cancer Might Worsen Outcomes Differentially by COX-2 Expression and ER Status: Exploratory Analysis of the REMAGUS02 Trial. J Clin Oncol. 2019 Mar 10;37(8):624-635. doi: 10.1200/JCO.18.00636. Epub 2019 Jan 31.

    PubMed 30702971

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, celecoxib and gemcitabine hydrochloride in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 400 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 400 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: Time between randomization and disease relapse or death from any cause, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01041781, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.

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