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Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

1. juli 2016 oppdatert av: Alliance for Clinical Trials in Oncology

A Phase II Study of Pemetrexed Disodium (ALIMTA®) Plus Bevacizumab in Patients With Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with bevacizumab may be an effective treatment for non-small cell lung cancer.

PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.

Studieoversikt

Status

Fullført

Forhold

Lungekreft

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

Primary

Assess the 3 month progression-free survival rate of the combination of pemetrexed disodium with bevacizumab in a patient population with stage IIIB (due to pleural effusion) or IV non-small cell lung cancer.

Secondary

Determine the tumor response rate in these patients.
Determine the effect of pemetrexed disodium in combination with bevacizumab on overall survival and duration of response in these patients.
Determine the toxicity profile of this drug regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Studietype

Intervensjonell

Registrering (Faktiske)

Fase

Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Alaska
  - Anchorage, Alaska, Forente stater, 99508
    - Providence Cancer Center
- Arizona
  - Scottsdale, Arizona, Forente stater, 85259-5499
    - Mayo Clinic Scottsdale
- Arkansas
  - Little Rock, Arkansas, Forente stater, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Castro Valley, California, Forente stater, 94546
    - Eden Medical Center
  - Hayward, California, Forente stater, 94545
    - Saint Rose Hospital
  - Oakland, California, Forente stater, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, Forente stater, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, Forente stater, 94602
    - Highland General Hospital at St. George's University School of Medicine
  - Pleasanton, California, Forente stater, 94588
    - Valley Care Medical Center
  - San Pablo, California, Forente stater, 94806
    - Doctors Medical Center - San Pablo Campus
- Florida
  - Jacksonville, Florida, Forente stater, 32224
    - Mayo Clinic - Jacksonville
- Georgia
  - Atlanta, Georgia, Forente stater, 30309
    - Piedmont Hospital
  - Atlanta, Georgia, Forente stater, 30342-1611
    - Northside Hospital Cancer Center
  - Atlanta, Georgia, Forente stater, 30342-1701
    - Saint Joseph's Hospital of Atlanta
  - Atlanta, Georgia, Forente stater, 30342
    - CCOP - Atlanta Regional
  - Austell, Georgia, Forente stater, 30106
    - WellStar Cobb Hospital
  - Decatur, Georgia, Forente stater, 30033
    - Charles B. Eberhart Cancer Center at DeKalb Medical Center
  - Lawrenceville, Georgia, Forente stater, 30045
    - Gwinnett Medical Center
  - Marietta, Georgia, Forente stater, 30060
    - Kennestone Cancer Center at Wellstar Kennestone Hospital
  - Riverdale, Georgia, Forente stater, 30274-2600
    - Southern Regional Medical Center
  - Savannah, Georgia, Forente stater, 31403-3089
    - Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  - Valdosta, Georgia, Forente stater, 31603
    - Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Illinois
  - Alton, Illinois, Forente stater, 62002
    - Saint Anthony's Hospital at Saint Anthony's Health Center
  - Aurora, Illinois, Forente stater, 60507
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, Forente stater, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, Forente stater, 61520
    - Graham Hospital
  - Carthage, Illinois, Forente stater, 62321
    - Memorial Hospital
  - Eureka, Illinois, Forente stater, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, Forente stater, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, Forente stater, 61401
    - Galesburg Clinic
  - Havana, Illinois, Forente stater, 62644
    - Mason District Hospital
  - Hopedale, Illinois, Forente stater, 61747
    - Hopedale Medical Complex
  - Joliet, Illinois, Forente stater, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Macomb, Illinois, Forente stater, 61455
    - Mcdonough District Hospital
  - Maywood, Illinois, Forente stater, 60153
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Mt. Vernon, Illinois, Forente stater, 62864
    - Good Samaritan Regional Health Center
  - Normal, Illinois, Forente stater, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Forente stater, 61761
    - Community Cancer Center
  - Ottawa, Illinois, Forente stater, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, Forente stater, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, Forente stater, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Peoria, Illinois, Forente stater, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Forente stater, 61614
    - Proctor Hospital
  - Peoria, Illinois, Forente stater, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, Forente stater, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, Forente stater, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, Forente stater, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, Forente stater, 61356
    - Perry Memorial Hospital
  - Spring Valley, Illinois, Forente stater, 61362
    - St. Margaret's Hospital
  - Urbana, Illinois, Forente stater, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, Forente stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, Forente stater, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Michigan City, Indiana, Forente stater, 46360
    - Saint Anthony Memorial Health Centers
  - Richmond, Indiana, Forente stater, 47374
    - Reid Hospital & Health Care Services, Incorporated
- Iowa
  - Ames, Iowa, Forente stater, 50010
    - McFarland Clinic, PC
  - Cedar Rapids, Iowa, Forente stater, 52403
    - Cedar Rapids Oncology Associates
  - Davenport, Iowa, Forente stater, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
  - Des Moines, Iowa, Forente stater, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, Forente stater, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Forente stater, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, Forente stater, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, Forente stater, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Forente stater, 50307
    - Mercy Capitol Hospital
  - Des Moines, Iowa, Forente stater, 50316-2301
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Mason City, Iowa, Forente stater, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Ottumwa, Iowa, Forente stater, 52501
    - McCreery Cancer Center at Ottumwa Regional
  - Sioux City, Iowa, Forente stater, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, Forente stater, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, Forente stater, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, Forente stater, 51104
    - Mercy Medical Center - Sioux City
- Kansas
  - Chanute, Kansas, Forente stater, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, Forente stater, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, Forente stater, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Kingman, Kansas, Forente stater, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Liberal, Kansas, Forente stater, 67901
    - Southwest Medical Center
  - Newton, Kansas, Forente stater, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, Forente stater, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, Forente stater, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, Forente stater, 67042
    - Cancer Center of Kansas, PA - Salina
  - Salina, Kansas, Forente stater, 67401
    - Tammy Walker Cancer Center at Salina Regional Health Center
  - Wellington, Kansas, Forente stater, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, Forente stater, 67203
    - Associates in Womens Health, PA - North Review
  - Wichita, Kansas, Forente stater, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, Forente stater, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, Forente stater, 67214
    - CCOP - Wichita
  - Wichita, Kansas, Forente stater, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Winfield, Kansas, Forente stater, 67156
    - Cancer Center of Kansas, PA - Winfield
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02118
    - Cancer Research Center at Boston Medical Center
- Michigan
  - Ann Arbor, Michigan, Forente stater, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, Forente stater, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Dearborn, Michigan, Forente stater, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Escanaba, Michigan, Forente stater, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, Forente stater, 48503
    - Hurley Medical Center
  - Flint, Michigan, Forente stater, 48503
    - Genesys Hurley Cancer Institute
  - Grosse Pointe Woods, Michigan, Forente stater, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, Forente stater, 49801
    - Green Bay Oncology, Limited - Iron Mountain
  - Jackson, Michigan, Forente stater, 49201
    - Foote Hospital
  - Lansing, Michigan, Forente stater, 48909
    - Sparrow Regional Cancer Center
  - Mount Clemens, Michigan, Forente stater, 48043
    - Ted B. Wahby Cancer Center at Mount Clemens General Hospital
  - Saginaw, Michigan, Forente stater, 48601
    - Seton Cancer Institute - Saginaw
  - Warren, Michigan, Forente stater, 48093
    - St. John Macomb Hospital
- Minnesota
  - Alexandria, Minnesota, Forente stater, 56308
  - Bemidji, Minnesota, Forente stater, 56601
    - MeritCare Clinic - Bemidji
  - Burnsville, Minnesota, Forente stater, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, Forente stater, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, Forente stater, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, Forente stater, 55805
    - St. Mary's - Duluth Clinic Cancer Center
  - Duluth, Minnesota, Forente stater, 55805
    - Miller-Dwan Medical Center
  - Edina, Minnesota, Forente stater, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, Forente stater, 56537
  - Fridley, Minnesota, Forente stater, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, Forente stater, 55350
    - Hutchinson Area Health Care
  - Lichfield, Minnesota, Forente stater, 55355
    - Meeker County Memorial Hospital
  - Maplewood, Minnesota, Forente stater, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Maplewood, Minnesota, Forente stater, 55109
    - Minnesota Oncology Hematology, PA at Maplewood Cancer Center
  - Minneapolis, Minnesota, Forente stater, 55415
    - Hennepin County Medical Center - Minneapolis
  - Minneapolis, Minnesota, Forente stater, 55407
    - Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
  - Montevideo, Minnesota, Forente stater, 56265
    - Chippewa County - Montevideo Hospital
  - Robbinsdale, Minnesota, Forente stater, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Medical Center
  - Rochester, Minnesota, Forente stater, 55905
    - Mayo Clinic Cancer Center
  - Saint Cloud, Minnesota, Forente stater, 56303
    - Coborn Cancer Center
  - Saint Louis Park, Minnesota, Forente stater, 55416
    - CCOP - Metro-Minnesota
  - Shakopee, Minnesota, Forente stater, 55379
    - Saint Francis Cancer Center
  - St Paul, Minnesota, Forente stater, 55102
    - St. Joseph's Hospital
  - St. Cloud, Minnesota, Forente stater, 56303
    - CentraCare Clinic - River Campus
  - St. Louis Park, Minnesota, Forente stater, 55416
    - Park Nicollet Health Services
  - St. Paul, Minnesota, Forente stater, 55102
    - United Hospital
  - St. Paul, Minnesota, Forente stater, 55101
    - Regions Hospital Cancer Care Center
  - Waconia, Minnesota, Forente stater, 55387
    - Ridgeview Medical Center
  - Woodbury, Minnesota, Forente stater, 55125
    - Woodwinds Health Campus
  - Woodbury, Minnesota, Forente stater, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- Mississippi
  - Pascagoula, Mississippi, Forente stater, 39581
    - Regional Cancer Center at Singing River Hospital
- Missouri
  - Cape Girardeau, Missouri, Forente stater, 63701
    - Saint Francis Medical Center
  - Gape Girardeau, Missouri, Forente stater, 63701
    - Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  - Kansas City, Missouri, Forente stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forente stater, 63141
    - David C. Pratt Cancer Center at St. John's Mercy
  - Saint Louis, Missouri, Forente stater, 63141
    - Arch Medical Services, Incorporated at Center for Cancer Care Research
  - Springfield, Missouri, Forente stater, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, Forente stater, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, Forente stater, 65807
    - Hulston Cancer Center at Cox Medical Center South
  - St. Louis, Missouri, Forente stater, 63131
    - Missouri Baptist Cancer Center
  - St. Louis, Missouri, Forente stater, 63141
    - CCOP - St. Louis-Cape Girardeau
- Montana
  - Billings, Montana, Forente stater, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, Forente stater, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, Forente stater, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, Forente stater, 59101
    - St. Vincent Healthcare
  - Billings, Montana, Forente stater, 59107-5100
    - Billings Clinic Cancer Center
  - Billings, Montana, Forente stater, 59107-7000
    - Deaconess Billings Clinic - Downtown
  - Bozeman, Montana, Forente stater, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, Forente stater, 59701
    - St. James Community Hospital
  - Great Falls, Montana, Forente stater, 59405
    - Big Sky Oncology
  - Great Falls, Montana, Forente stater, 59405
    - Sletten Regional Cancer Institute at Benefis Healthcare
  - Helena, Montana, Forente stater, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, Forente stater, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, Forente stater, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, Forente stater, 59901
    - Kalispell Medical Oncology
  - Missoula, Montana, Forente stater, 59801
    - Community Medical Center
  - Missoula, Montana, Forente stater, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, Forente stater, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, Forente stater, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Kearney, Nebraska, Forente stater, 68848-1990
    - Good Samaritan Cancer Center at Good Samaritan Hospital
  - Lincoln, Nebraska, Forente stater, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, Forente stater, 68106
    - CCOP - Missouri Valley Cancer Consortium
- New York
  - Glens Falls, New York, Forente stater, 12801
    - Adirondack Cancer Care - Glens Falls
- North Carolina
  - Asheboro, North Carolina, Forente stater, 27203-5400
    - Randolph Hospital
  - Goldsboro, North Carolina, Forente stater, 27534
    - Wayne Memorial Hospital, Incorporated
  - Greensboro, North Carolina, Forente stater, 27403-1198
    - Moses Cone Regional Cancer Center at Wesley Long Community Hospital
  - Hendersonville, North Carolina, Forente stater, 28791
    - Pardee Memorial Hospital
  - Reidsville, North Carolina, Forente stater, 27320
    - Annie Penn Cancer Center
  - Rutherfordton, North Carolina, Forente stater, 28139
    - Rutherford Hospital
  - Statesville, North Carolina, Forente stater, 28677
    - Iredell Memorial Hospital
- North Dakota
  - Bismarck, North Dakota, Forente stater, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, Forente stater, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, Forente stater, 58501
    - Cancer Care Center at Medcenter One Hospital
  - Bismarck, North Dakota, Forente stater, 58502
    - St. Alexius Medical Center
  - Fargo, North Dakota, Forente stater, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, Forente stater, 58122
    - MeritCare Medical Group
  - Grand Forks, North Dakota, Forente stater, 58201
    - Altru Cancer Center at Altru Hospital
- Ohio
  - Chillicothe, Ohio, Forente stater, 45601
    - Adena Regional Medical Center
  - Columbus, Ohio, Forente stater, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, Forente stater, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, Forente stater, 43215
    - CCOP - Columbus
  - Columbus, Ohio, Forente stater, 43228
    - Doctors Hospital at Ohio Health
  - Columbus, Ohio, Forente stater, 43215
    - Grant Riverside Cancer Services
  - Dayton, Ohio, Forente stater, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, Forente stater, 45405
    - Grandview Hospital
  - Dayton, Ohio, Forente stater, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, Forente stater, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, Forente stater, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, Forente stater, 45429
    - CCOP - Dayton
  - Delaware, Ohio, Forente stater, 43015
    - Grady Memorial Hospital
  - Findlay, Ohio, Forente stater, 45840
    - Blanchard Valley Medical Associates
  - Kettering, Ohio, Forente stater, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, Forente stater, 43130
    - Fairfield Medical Center
  - Marietta, Ohio, Forente stater, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Middletown, Ohio, Forente stater, 45044
    - Middletown Regional Hospital
  - Newark, Ohio, Forente stater, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Springfield, Ohio, Forente stater, 45505
    - Community Hospital of Springfield and Clark County
  - Springfield, Ohio, Forente stater, 45504
    - Mercy Medical Center
  - Troy, Ohio, Forente stater, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Westerville, Ohio, Forente stater, 43081
    - Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
  - Wright-Patterson Afb, Ohio, Forente stater, 45433-5529
    - United States Air Force Medical Center - Wright-Patterson
  - Xenia, Ohio, Forente stater, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Zanesville, Ohio, Forente stater, 43701
    - Genesis - Good Samaritan Hospital
- Oklahoma
  - Tulsa, Oklahoma, Forente stater, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Oregon
  - Gresham, Oregon, Forente stater, 97030
    - Legacy Mount Hood Medical Center
  - Milwaukie, Oregon, Forente stater, 97222
    - Providence Milwaukie Hospital
  - Portland, Oregon, Forente stater, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, Forente stater, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, Forente stater, 97225
    - Providence St. Vincent Medical Center
  - Portland, Oregon, Forente stater, 97210
    - Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
  - Portland, Oregon, Forente stater, 97227
    - Legacy Emanuel Hospital and Health Center & Children's Hospital
  - Salem, Oregon, Forente stater, 97309-5014
    - Salem Hospital Regional Cancer Care Services
  - Tualatin, Oregon, Forente stater, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Allentown, Pennsylvania, Forente stater, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - Sayre, Pennsylvania, Forente stater, 18840
    - Guthrie Cancer Center at Guthrie Clinic Sayre
- South Carolina
  - Anderson, South Carolina, Forente stater, 29621
    - AnMed Health Cancer Center
  - Charleston, South Carolina, Forente stater, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Spartanburg, South Carolina, Forente stater, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, Forente stater, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - Rapid City, South Dakota, Forente stater, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, Forente stater, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, Forente stater, 57117-5039
    - Sioux Valley Hospital and University of South Dakota Medical Center
  - Sioux Falls, South Dakota, Forente stater, 57105
    - Medical X-Ray Center, PC
- Tennessee
  - Knoxville, Tennessee, Forente stater, 37916
    - Thompson Cancer Survival Center
- Texas
  - Houston, Texas, Forente stater, 77030-4009
    - M.D. Anderson Cancer Center at University of Texas
- Virginia
  - Danville, Virginia, Forente stater, 24541
    - Danville Regional Medical Center
- Washington
  - Bellingham, Washington, Forente stater, 98225
    - St. Joseph Cancer Center
  - Bremerton, Washington, Forente stater, 98310
    - Olympic Hematology and Oncology
  - Seattle, Washington, Forente stater, 98104
    - Harborview Medical Center
  - Seattle, Washington, Forente stater, 98104
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, Forente stater, 98104
    - Minor and James Medical, PLLC
  - Seattle, Washington, Forente stater, 98112
    - Group Health Central Hospital
  - Seattle, Washington, Forente stater, 98122-4307
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Seattle, Washington, Forente stater, 98122
    - Polyclinic First Hill
  - Seattle, Washington, Forente stater, 98195-6043
    - University Cancer Center at University of Washington Medical Center
  - Spokane, Washington, Forente stater, 99202
    - Cancer Care Northwest - Spokane South
  - Vancouver, Washington, Forente stater, 98668
    - Southwest Washington Medical Center Cancer Center
  - Wenatchee, Washington, Forente stater, 98801-2028
    - Wenatchee Valley Medical Center
- Wisconsin
  - Green Bay, Wisconsin, Forente stater, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, Forente stater, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, Forente stater, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Green Bay, Wisconsin, Forente stater, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital
  - La Crosse, Wisconsin, Forente stater, 54601
    - Franciscan Skemp Healthcare
  - Marinette, Wisconsin, Forente stater, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Oconto Falls, Wisconsin, Forente stater, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Sturgeon Bay, Wisconsin, Forente stater, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
- Wyoming
  - Sheridan, Wyoming, Forente stater, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Histologically or cytologically diagnosed stage IIIB or IV non-small cell lung cancer
- Stage IIIB patients must have pleural effusion
  - No symptomatic serosal effusion (grade 2 dyspnea) that is not amenable to drainage
- Mixed histology allowed if all components consistent with non-small cell lung cancer
- Tumors with squamous cell histology feature are allowed
Must have measurable disease with at least one lesion with a longest diameter accurately measured as ≥ 2.0 cm with conventional techniques or as ≥ 1.0 cm with spiral CT
- Large ( > 4 cm) centrally located lesions or large lesions in close proximity to major blood vessels should receive palliative radiation
  - The irradiated lesion should not be a target lesion
Previously treated with one chemotherapy regimen in the neoadjuvant, adjuvant, or advanced disease setting
No symptomatic, untreated, or uncontrolled CNS metastases
- CNS metastases treated with prior whole brain radiotherapy allowed

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 12 weeks
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/ mm^3
Hemoglobin ≥ 9 g/dL
Bilirubin ≤ 1.5 times upper limit of normal (ULN) or direct bilirubin normal
AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
Creatinine clearance ≥ 45 mL/min
Urine protein:creatinine ratio < 1.0
Pregnant or nursing women are ineligible
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study participation
No seizure disorder
No clinically significant infection
No other second primary malignancy within the past 5 years except carcinoma in situ of the cervix, non-melanomatous skin cancer, or low-grade (Gleason score ≤ 6) localized prostate cancer
No hypertension or labile hypertension
No history of poor compliance with antihypertensive medications
No angina pectoris
No congestive heart failure within the past 3 months unless ejection fraction > 40%
No myocardial infarction within the past 6 months
No cardiac arrhythmia
No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
No active or recent history of hemoptysis
- Hemoptysis resolved > 2 weeks ago with measures such as palliative radiation therapy (i.e., 3,000 cGy over 10 fractions), arteriographic embolization, or endobronchial interventions (e.g., photodynamic therapy or brachytherapy) is acceptable
No diabetes
No prior serious, non-healing wounds, ulcers, or bone fractures
No history of stroke within the past 6 months
No history of abdominal fistula or gastrointestinal perforation
No intra-abdominal abscess within the past 6 months
Not at greater than average risk of bleeding
No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

No aspirin at doses ≥ 1.3 grams per day within 10 days prior to or 10 days after pemetrexed disodium treatment
No chemotherapy within the past 3 weeks (6 weeks for mitomycin C or nitrosoureas)
No immunotherapy or biologic therapy within the past 2 weeks
No full field radiation therapy within the past 4 weeks or limited field radiation therapy within the past 2 weeks
- The site of previous radiotherapy should have evidence of progressive disease if it is the only site of disease
No prior post pelvic radiation
No prior use of pemetrexed disodium
No prior radiation to > 25% of the marrow cavity
No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks
No minor surgery within the past 2 weeks except insertion of a vascular access device
No concurrent major surgery
No other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary therapy considered investigational within the past 4 weeks
No concurrent use of Hypericum perforatum (St. John's wort)
No concurrent anticoagulant use
- Low-dose warfarin or heparin for deep venous thrombosis prophylaxis allowed

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: N/A
Intervensjonsmodell: Enkeltgruppeoppdrag
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: pemetrexed + bevacizumab Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years.	Legemiddel: pemetrexed dinatrium Biologisk: bevacizumab

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Proportion of progression-free patients at 3 months Tidsramme: at 3 months	at 3 months

Sekundære resultatmål

Resultatmål	Tidsramme
Progresjonsfri overlevelse Tidsramme: Inntil 5 år	Inntil 5 år
Total overlevelse Tidsramme: Inntil 5 år	Inntil 5 år
Varighet av svar Tidsramme: Inntil 5 år	Inntil 5 år
Tid til behandlingssvikt Tidsramme: Inntil 5 år	Inntil 5 år
Response (complete and partial) as assessed by RECIST criteria Tidsramme: Up to 5 years	Up to 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Studiestol: Alex A. Adjei, MD, PhD, Roswell Park Cancer Institute

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Adjei AA, Mandrekar SJ, Dy GK, Molina JR, Adjei AA, Gandara DR, Ziegler KL, Stella PJ, Rowland KM Jr, Schild SE, Zinner RG. Phase II trial of pemetrexed plus bevacizumab for second-line therapy of patients with advanced non-small-cell lung cancer: NCCTG and SWOG study N0426. J Clin Oncol. 2010 Feb 1;28(4):614-9. doi: 10.1200/JCO.2009.23.6406. Epub 2009 Oct 19.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2006

Primær fullføring (Faktiske)

1. mai 2007

Studiet fullført (Faktiske)

1. april 2010

Datoer for studieregistrering

Først innsendt

20. desember 2005

Først innsendt som oppfylte QC-kriteriene

20. desember 2005

Først lagt ut (Anslag)

22. desember 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. juli 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

NCCTG-N0426
NCI-2012-02681 (Registeridentifikator: CTRP (Clinical Trials Reporting System))
SWOG-N0426
CDR0000456427 (Registeridentifikator: PDQ (Physician Data Query))

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Lungekreft

Yonsei University

Fullført

Effekter av dexmedetomidin på respirasjonsmekanikk og oksygenering under én lungeventilasjon med kronisk obstruktiv lungesykdom

KOLS, One Lung Ventilation
Novartis Pharmaceuticals

Fullført

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care i behandling av pasienter med avanserte nevroendokrine svulster (GI eller Lung Origin) (RADIANT-4)

Nevroendokrine svulster | Avansert NET av GI Origin | Advanced NET of Lung Origin

Forente stater, Colombia, Italia, Taiwan, Storbritannia, Belgia, Tsjekkia, Tyskland, Japan, Saudi-Arabia, Canada, Nederland, Spania, Korea, Republikken, Libanon, Østerrike, Kina, Hellas, Sør-Afrika, Thailand, Ungarn, Tyrkia, Polen, Slov... og mer
The Cleveland Clinic

Tilbaketrukket

Bruken av konstantstrømningsteknikk for å bestemme det nedre bøyepunktet for trykk-volumkurven og indre PEEP under en-lungeventilasjon

One Lung Ventillation (OLV) | To lungeventilasjon (TLV) | Positivt End Expiratory Pressure (PEEP) | Null sluttekspirasjonstrykk (ZEEP)
Assiut University

Har ikke rekruttert ennå

Polypropylen vs polyglactin i suturering av lungen

Lungekreft | Lungeskade | Bleb Lung
RenJi Hospital

Rekruttering

Prospective Genomics Initiative on Multiple Synchronous Lung Cancer (PGI-MSLC)

Multiple Synchronous Lung Cancers (MSLC)

Kina
Poitiers University Hospital

Fullført

Procore Needle®s interesse for diagnose av lungekreft

Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore
University of Lorraine

Fullført

Thorakoskopi for idiopatisk pneumothorax hos barn (PNOPED)

Bare barn | Spontan pneumothorax | Idiopatisk pneumotoraks | Bleb Lung

Frankrike
AHS Cancer Control Alberta
Cross Cancer Institute

Fullført

Fase II-studie av konsoliderende thoraxstrålebehandling for småcellet lungekreft i omfattende stadium

Omfattende Stage Small Cel Lung Cancer

Canada
Damascus University
University Children's Hospital

Fullført

Effekten av dexmedetomidin på oksygen under én lungeventilasjon i pediatrisk kirurgi. (RCT)

Esophageal atresi | One Lung Ventilation OLV | Hydrocystoma | Pneumonektomi | Pleura; Abscess

Den syriske arabiske republikk
Ministry of Health, Saudi Arabia

Har ikke rekruttert ennå

Koffein som en adjuvant terapi for sent premature spedbarn med pustebesvær (CAT/LPT)

Luftveissykdom | Prematuritet | Ventilator Lung; Nyfødt

Kliniske studier på pemetrexed dinatrium

Rigel Pharmaceuticals

Fullført

Effekt- og sikkerhetsstudie av Fostamatinib Dinatrium-tabletter for å behandle T-celle lymfom

T-celle lymfom

Forente stater, Canada
Boehringer Ingelheim

Avsluttet

BIBF 1120 i kombinasjon med pemetrexed ved avansert ikke-småcellet lungekreft (NSCLC)

Karsinom, ikke-småcellet lunge

Japan
Rongjie Tao
National Natural Science Foundation of China

Ukjent

Høydose Pemetrexed for å behandle lungeadenokarsinom med hjernemetastaser

Hjernemetastaser

Kina
Northwestern University
National Cancer Institute (NCI)

Ukjent

Pemetrexed dinatrium ved behandling av pasienter med tilbakevendende maligne gliomer, primært CNS-lymfom eller hjernemetastaser

Lymfom | Svulster i hjernen og sentralnervesystemet | Metastatisk kreft

Forente stater
Eli Lilly and Company

Fullført

En studie av hjemmeadministrasjon av pemetrexed som vedlikeholdsbehandling for avansert ikke-småcellet lungekreft (NSCLC)

Ikke-småcellet lungekreft Metastatisk | Ikke-småcellet neoplasma i lungen | Ikke-småcellet lungekreft stadium IIIB

Storbritannia, Sverige
Shanghai Shengdi Pharmaceutical Co., Ltd

Har ikke rekruttert ennå

En fase II/III-studie av Adebrelimab i kombinasjon med SHR-8068 og kjemoterapi hos avanserte eller metastatiske NSCLC-pasienter

Ikke-plateepitel Ikke-småcellet lungekreft

Kina
Pfizer

Avsluttet

Forsøk med Pemetrexed med eller uten PF-3512676 ved avansert ikke-småcellet lungekreft

Karsinom, ikke-småcellet lunge

Forente stater, Tyskland, Italia
Ain Shams University

Ukjent

Fire versus seks sykluser av Pemetrexed/Platinum for MPM

Ondartet pleural mesothelioma

Egypt
Norwegian University of Science and Technology
St. Olavs Hospital

Avsluttet

Pemetrexed ved avansert ikke-småcellet lungekreft: ved progresjon vs vedlikeholdsterapi etter induksjonskjemoterapi (IDA)

Karsinom, ikke-småcellet lunge

Norge
Spanish Lung Cancer Group

Avsluttet

Studie av Pemetrexed Plus Cisplatin som førstelinjebehandling hos pasienter med avansert ikke-plateepitel-NSCLC (Phalcis)

Karsinom, ikke-småcellet lunge

Spania

Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

A Phase II Study of Pemetrexed Disodium (ALIMTA®) Plus Bevacizumab in Patients With Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Faktiske)

Fase

Kontakter og plasseringer

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tidsramme

Sekundære resultatmål

Resultatmål

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Samarbeidspartnere

Etterforskere

Publikasjoner og nyttige lenker

Generelle publikasjoner

Studierekorddatoer

Studer hoveddatoer

Studiestart

Primær fullføring (Faktiske)

Studiet fullført (Faktiske)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Anslag)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Kliniske studier på Lungekreft

Kliniske studier på pemetrexed dinatrium

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Mongolia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder