Lung Cancer Clinical Trial
Official title:
A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer
Verified date | June 2018 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 313 |
Est. completion date | March 2018 |
Est. primary completion date | January 17, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Kapiolani Medical Center at Pali Momi | 'Aiea | Hawaii |
United States | Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania |
United States | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan |
United States | Toledo Clinic Cancer Centers - Adrian | Adrian | Michigan |
United States | McFarland Clinic, PC | Ames | Iowa |
United States | Island Hospital Cancer Care Center at Island Hospital | Anacortes | Washington |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | Regional Medical Center | Anniston | Alabama |
United States | Mission Hospitals - Memorial Campus | Asheville | North Carolina |
United States | Auburn Regional Center for Cancer Care | Auburn | Washington |
United States | Harold Alfond Center for Cancer Care | Augusta | Maine |
United States | Rush-Copley Cancer Care Center | Aurora | Illinois |
United States | Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland |
United States | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland |
United States | Veterans Affairs Medical Center - Baltimore | Baltimore | Maryland |
United States | CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge | Louisiana |
United States | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan |
United States | Overlake Cancer Center at Overlake Hospital Medical Center | Bellevue | Washington |
United States | St. Joseph Cancer Center | Bellingham | Washington |
United States | Sanford Clinic North-Bemidji | Bemidji | Minnesota |
United States | National Naval Medical Center | Bethesda | Maryland |
United States | Constantinou, Costas L MD (UIA Investigator) | Bettendorf | Iowa |
United States | Hematology Oncology Associates of the Quad Cities | Bettendorf | Iowa |
United States | Beverly Hospital | Beverly | Massachusetts |
United States | Mecosta County Medical Center | Big Rapids | Michigan |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
United States | Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota |
United States | Mid Dakota Clinic, PC | Bismarck | North Dakota |
United States | Sanford Bismarck Medical Center | Bismarck | North Dakota |
United States | St. Alexius Medical Center Cancer Center | Bismarck | North Dakota |
United States | Illinois CancerCare - Bloomington | Bloomington | Illinois |
United States | St. Joseph Medical Center | Bloomington | Illinois |
United States | Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho |
United States | Central Care Cancer Center at Carrie J. Babb Cancer Center | Bolivar | Missouri |
United States | Boston University Cancer Research Center | Boston | Massachusetts |
United States | Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Wood County Oncology Center | Bowling Green | Ohio |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | St. Joseph's Medical Center | Brainerd | Minnesota |
United States | Cox Cancer Center Branson | Branson | Missouri |
United States | Skaggs Cancer Center at Skaggs Regional Medical Center | Branson | Missouri |
United States | Olympic Hematology and Oncology | Bremerton | Washington |
United States | Caritas St. Elizabeth's Medical Center | Brighton | Massachusetts |
United States | Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York |
United States | Veterans Affairs Medical Center - Buffalo | Buffalo | New York |
United States | Highline Medical Center Cancer Center | Burien | Washington |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Cooper Hospital University Medical Center | Camden | New Jersey |
United States | Illinois CancerCare - Canton | Canton | Illinois |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Illinois CancerCare - Carthage | Carthage | Illinois |
United States | Rocky Mountain Oncology | Casper | Wyoming |
United States | Helen G Nassif Community Cancer Center | Cedar Rapids | Iowa |
United States | Iowa Blood and Cancer Care | Cedar Rapids | Iowa |
United States | Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa |
United States | St. Luke's Hospital | Cedar Rapids | Iowa |
United States | Providence Centralia Hospital | Centralia | Washington |
United States | Resurrection Medical Center | Chicago | Illinois |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | University of Illinois Cancer Center | Chicago | Illinois |
United States | Marshfield Clinic - Chippewa Center | Chippewa Falls | Wisconsin |
United States | Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio |
United States | Medical Oncology and Hematology Associates - West Des Moines | Clive | Iowa |
United States | Mercy Cancer Center - West Lakes | Clive | Iowa |
United States | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri |
United States | Veterans Administration/Harry S Truman Memorial Hospital | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | John B. Amos Cancer Center | Columbus | Georgia |
United States | New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord | New Hampshire |
United States | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | Genesis Regional Cancer Center at Genesis Medical Center | Davenport | Iowa |
United States | CCOP - Dayton | Dayton | Ohio |
United States | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio |
United States | Dayton CCOP | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Oakwood Hospital | Dearborn | Michigan |
United States | Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia |
United States | North Broward Medical Center | Deerfield Beach | Florida |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa |
United States | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa |
United States | Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Essentia Health - Duluth Clinic | Duluth | Minnesota |
United States | Miller - Dwan Medical Center | Duluth | Minnesota |
United States | Duke Cancer Institute | Durham | North Carolina |
United States | Veterans Affairs Medical Center - Durham | Durham | North Carolina |
United States | Veterans Administration New Jersey Health Care System | East Orange | New Jersey |
United States | CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York |
United States | Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Swedish Medical Center-Edmonds | Edmonds | Washington |
United States | Union Hospital of Cecil County | Elkton | Maryland |
United States | Community Cancer Center | Elyria | Ohio |
United States | Hematology Oncology Center | Elyria | Ohio |
United States | Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan |
United States | Eureka Community Hospital | Eureka | Illinois |
United States | Illinois CancerCare - Eureka | Eureka | Illinois |
United States | Evanston Hospital | Evanston | Illinois |
United States | Providence Regional Cancer Partnership | Everett | Washington |
United States | Center for Cancer Care at Exeter Hospital | Exeter | New Hampshire |
United States | Dakota Cancer Institute at Dakota Clinic - South University | Fargo | North Dakota |
United States | Essentia Health Cancer Center-South University Clinic | Fargo | North Dakota |
United States | Sanford Clinic North-Fargo | Fargo | North Dakota |
United States | Sanford Clinic North-Fargo | Fargo | North Dakota |
United States | Sanford Roger Maris Cancer Center | Fargo | North Dakota |
United States | Saint Francis Hospital | Federal Way | Washington |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | McLeod Regional Medical Center | Florence | South Carolina |
United States | Front Range Cancer Specialists | Fort Collins | Colorado |
United States | Poudre Valley Hospital | Fort Collins | Colorado |
United States | Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia |
United States | Middletown Regional Hospital | Franklin | Ohio |
United States | Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia |
United States | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota |
United States | Northeast Georgia Medical Center | Gainesville | Georgia |
United States | Galesburg Clinic, PC | Galesburg | Illinois |
United States | Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls | New York |
United States | Addison Gilbert Hospital | Gloucester | Massachusetts |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Genesys Regional Medical Center | Grand Blanc | Michigan |
United States | Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota |
United States | Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | Benefis Sletten Cancer Institute | Great Falls | Montana |
United States | Big Sky Oncology | Great Falls | Montana |
United States | Great Falls Clinic - Main Facility | Great Falls | Montana |
United States | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin |
United States | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | Wayne Hospital | Greenville | Ohio |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | John R. Marsh Cancer Center at Washington County Hospital | Hagerstown | Maryland |
United States | Meritus Medical Center | Hagerstown | Maryland |
United States | Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Illinois CancerCare - Havana | Havana | Illinois |
United States | St. Peter's Hospital | Helena | Montana |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Hawaii Medical Center - East | Honolulu | Hawaii |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Oncare Hawaii Inc-POB II | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Kuakini | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Lusitana | Honolulu | Hawaii |
United States | OnCare Hawaii-Liliha | Honolulu | Hawaii |
United States | Queen's Cancer Institute at Queen's Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital, Incorporated | Honolulu | Hawaii |
United States | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii |
United States | University of Hawaii | Honolulu | Hawaii |
United States | New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett | New Hampshire |
United States | Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington | West Virginia |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | St. Francis Hospital Cancer Care Services | Indianapolis | Indiana |
United States | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa |
United States | Veterans Affairs Medical Center - Iowa City | Iowa City | Iowa |
United States | Dickinson County Healthcare System | Iron Mountain | Michigan |
United States | Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan |
United States | Swedish Medical Center - Issaquah Campus | Issaquah | Washington |
United States | Allegiance Health | Jackson | Michigan |
United States | Foote Memorial Hospital | Jackson | Michigan |
United States | University of Mississippi Cancer Clinic | Jackson | Mississippi |
United States | Mercy Regional Cancer Center | Janesville | Wisconsin |
United States | Goldschmidt Cancer Center | Jefferson City | Missouri |
United States | NEA Medical Clinic - East Matthews | Jonesboro | Arkansas |
United States | Castle Medical Center | Kailua | Hawaii |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney | Nebraska |
United States | Columbia Basin Hematology | Kennewick | Washington |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois |
United States | Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport | Tennessee |
United States | Kinston Medical Specialists | Kinston | North Carolina |
United States | Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin |
United States | La Grange Memorial Hospital | La Grange | Illinois |
United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
United States | Lakes Region General Hospital | Laconia | New Hampshire |
United States | Monter Cancer Center of the North Shore-LIJ Health System | Lake Success | New York |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | Cancer Centers of Southwest Oklahoma, LLC - Lawton | Lawton | Oklahoma |
United States | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware |
United States | Saint Joseph Regional Medical Center | Lewiston | Idaho |
United States | Central Baptist Hospital | Lexington | Kentucky |
United States | Kauai Medical Clinic | Lihue | Hawaii |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | St. Rita's Medical Center | Lima | Ohio |
United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | St. Mary Mercy Hospital | Livonia | Michigan |
United States | Dana-Farber Cancer Institute at Londonderry | Londonderry | New Hampshire |
United States | Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California |
United States | Southeastern Regional Medical Center | Lumberton | North Carolina |
United States | Lynchburg Hematology-Oncology Clinic | Lynchburg | Virginia |
United States | Illinois CancerCare - Macomb | Macomb | Illinois |
United States | Norris Cotton Cancer Center-Manchester | Manchester | New Hampshire |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York |
United States | Holy Family Memorial Medical Center Cancer Care Center | Manitowoc | Wisconsin |
United States | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota |
United States | Minnesota Oncology - Maplewood | Maplewood | Minnesota |
United States | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin |
United States | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin |
United States | Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville | Virginia |
United States | Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City | Iowa |
United States | Northwest Ohio Oncology Center | Maumee | Ohio |
United States | Toledo Clinic Cancers Centers - Maumee | Maumee | Ohio |
United States | Saint Anthony Memorial Health Centers | Michigan City | Indiana |
United States | Middlesex Hospital Cancer Center | Middletown | Connecticut |
United States | Orange Regional Medical Center | Middletown | New York |
United States | Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center | Milford | Massachusetts |
United States | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
United States | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota |
United States | Marshfield Clinic - Minocqua Center | Minocqua | Wisconsin |
United States | Trinity CancerCare Center | Minot | North Dakota |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Garneau, Stewart C MD (UIA Investigator) | Moline | Illinois |
United States | Porubcin, Michael (UIA Investigator) | Moline | Illinois |
United States | Spector, David MD (UIA Investigator) | Moline | Illinois |
United States | Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline | Illinois |
United States | Illinois CancerCare - Monmouth | Monmouth | Illinois |
United States | OSF Holy Family Medical Center | Monmouth | Illinois |
United States | Community Cancer Center of Monroe | Monroe | Michigan |
United States | Louisiana State University Health Sciences Center - Monroe | Monroe | Louisiana |
United States | Mercy Memorial Hospital - Monroe | Monroe | Michigan |
United States | Toledo Clinic Cancer Centers - Monroe | Monroe | Michigan |
United States | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia |
United States | Skagit Valley Hospital Cancer Care Center | Mount Vernon | Washington |
United States | Camino Medical Group - Treatment Center | Mountain View | California |
United States | Palo Alto Medical Foundation-Camino Division | Mountain View | California |
United States | D.N. Greenwald Center | Mukwonago | Wisconsin |
United States | Mercy General Health Partners | Muskegon | Michigan |
United States | Hematology Oncology Consultants - Naperville | Naperville | Illinois |
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
United States | Interim LSU Public Hospital | New Orleans | Louisiana |
United States | Louisiana State University Health Science Center | New Orleans | Louisiana |
United States | Westfields Hospital/Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | New Ulm Medical Center | New Ulm | Minnesota |
United States | New York Weill Cornell Cancer Center at Cornell University | New York | New York |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | BroMenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center | Normal | Illinois |
United States | Illinois CancerCare - Community Cancer Center | Normal | Illinois |
United States | Mercy Clinic Oklahoma Communities Inc-Norman | Norman | Oklahoma |
United States | Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton | Virginia |
United States | Advocate Christ Medical Center | Oak Lawn | Illinois |
United States | Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin |
United States | Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin |
United States | Mercy Clinic Oklahoma Communities Inc-Mercy Health Center | Oklahoma City | Oklahoma |
United States | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma |
United States | Providence St. Peter Hospital Regional Cancer Center | Olympia | Washington |
United States | St. Charles Mercy Hospital | Oregon | Ohio |
United States | Toledo Clinic - Oregon | Oregon | Ohio |
United States | Florida Hospital - Orlando | Orlando | Florida |
United States | Community Hospital of Ottawa | Ottawa | Illinois |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois |
United States | Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois |
United States | McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa |
United States | Granville Medical Center | Oxford | North Carolina |
United States | Palo Alto Medical Foundation | Palo Alto | California |
United States | Feather River Hospital Cancer Center | Paradise | California |
United States | Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi |
United States | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois |
United States | Illinois CancerCare - Pekin | Pekin | Illinois |
United States | Pekin Cancer Treatment Center | Pekin | Illinois |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Illinois CancerCare-Peoria | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois |
United States | OSF St. Francis Medical Center | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois CancerCare - Peru | Peru | Illinois |
United States | Illinois Valley Community Hospital | Peru | Illinois |
United States | FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst | North Carolina |
United States | PCR Oncology | Pismo Beach | California |
United States | St. Joseph Mercy Oakland | Pontiac | Michigan |
United States | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan |
United States | Harrison Poulsbo Hematology and Onocology | Poulsbo | Washington |
United States | Illinois CancerCare - Princeton | Princeton | Illinois |
United States | Miriam Hospital | Providence | Rhode Island |
United States | Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island |
United States | Good Samaritan Cancer Center | Puyallup | Washington |
United States | Duke Health Raleigh Hospital | Raleigh | North Carolina |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
United States | Renown Institute for Cancer at Renown Regional Medical Center | Reno | Nevada |
United States | Marshfield Clinic at James Beck Cancer Center | Rhinelander | Wisconsin |
United States | Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin |
United States | Marshfield Clinic - Rice Lake Center | Rice Lake | Wisconsin |
United States | Reid Hospital & Health Care Services | Richmond | Indiana |
United States | Valley Hospital - Ridgewood | Ridgewood | New Jersey |
United States | Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota |
United States | Lipson Cancer and Blood Center at Rochester General Hospital | Rochester | New York |
United States | Swedish-American Regional Cancer Center | Rockford | Illinois |
United States | Person Memorial Hospital | Roxboro | North Carolina |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | Missouri Baptist Cancer Center | Saint Louis | Missouri |
United States | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Park Nicollet Cancer Center | Saint Louis Park | Minnesota |
United States | Regions Hospital Cancer Care Center | Saint Paul | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Naval Medical Center - San Diego | San Diego | California |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Veterans Affairs Medical Center - San Francisco | San Francisco | California |
United States | Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Group Health Central Hospital | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington |
United States | University Cancer Center at University of Washington Medical Center | Seattle | Washington |
United States | North Puget Oncology at United General Hospital | Sedro-Woolley | Washington |
United States | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota |
United States | St. Nicholas Hospital | Sheboygan | Wisconsin |
United States | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming |
United States | Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport | Louisiana |
United States | Highland Clinic | Shreveport | Louisiana |
United States | Mercy Medical Center - Sioux City | Sioux City | Iowa |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | St. Luke's Regional Medical Center | Sioux City | Iowa |
United States | Dana-Farber/Brigham and Women's Cancer Center at South Shore | South Weymouth | Massachusetts |
United States | Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield | Michigan |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | Evergreen Hematology and Oncology, PS | Spokane | Washington |
United States | Illinois CancerCare - Spring Valley | Spring Valley | Illinois |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri |
United States | Mercy-Springfield | Springfield | Missouri |
United States | St. John's Regional Health Center | Springfield | Missouri |
United States | Iredell Memorial Hospital | Statesville | North Carolina |
United States | Marshfield Clinic at Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin |
United States | Flower Hospital Cancer Center | Sylvania | Ohio |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
United States | Veterans Affairs Medical Center - Syracuse | Syracuse | New York |
United States | Allenmore Hospital | Tacoma | Washington |
United States | Multicare Health System - Tacoma General Hospital | Tacoma | Washington |
United States | Northwest CCOP | Tacoma | Washington |
United States | Saint Clare Hospital | Tacoma | Washington |
United States | Saint Joseph Medical Center | Tacoma | Washington |
United States | Celilo Cancer Center at Mid-Columbia Medical Center | The Dalles | Oregon |
United States | Mercy Hospital of Tiffin | Tiffin | Ohio |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | Medical University of Ohio Cancer Center | Toledo | Ohio |
United States | St. Anne Mercy Hospital | Toledo | Ohio |
United States | St. Vincent Mercy Medical Center | Toledo | Ohio |
United States | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio |
United States | Toledo Hospital | Toledo | Ohio |
United States | University of Toledo | Toledo | Ohio |
United States | Stormont-Vail Regional Health Center | Topeka | Kansas |
United States | Munson Medical Center | Traverse City | Michigan |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Maui Memorial Medical Center | Wailuku | Hawaii |
United States | Pacific Cancer Institute - Maui | Wailuku | Hawaii |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Marion L. Shepard Cancer Center at Beaufort County Hospital | Washington | North Carolina |
United States | Veterans Affairs Medical Center - Washington, DC | Washington | District of Columbia |
United States | Washington Cancer Institute at Washington Hospital Center | Washington | District of Columbia |
United States | Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | Wenatchee Valley Medical Center | Wenatchee | Washington |
United States | Methodist West Hospital | West Des Moines | Iowa |
United States | Diagnostic and Treatment Center | Weston | Wisconsin |
United States | Marshfield Clinic - Weston Center | Weston | Wisconsin |
United States | Veterans Affairs Medical Center - White River Junction | White River Junction | Vermont |
United States | White River Junction Veteran Administration Medical Center | White River Junction | Vermont |
United States | Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota |
United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
United States | Minnesota Oncology - Woodbury | Woodbury | Minnesota |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
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. Pha — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Time between randomization and disease relapse or death from any cause, assessed up to 5 years | |
Secondary | 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. | Time between randomization and death from any cause, assessed up to 5 years | |
Secondary | 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 | Up to 5 years | |
Secondary | 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 | Up to 5 years | |
Secondary | 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. | Up to 5 years | |
Secondary | 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. | Up to 5 years | |
Secondary | 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. | Up to 5 years |
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