- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00436332
S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma
A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC)
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 erlotinib together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine overall survival of patients with stage IIIB or IV bronchioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features treated with erlotinib hydrochloride and bevacizumab.
Secondary
- Determine the progression-free survival of patients treated with this regimen.
- Compare, preliminarily, response as assessed by RECIST criteria vs response as assessed by a central computer-assisted image-analysis system in patients with measurable disease treated with this regimen.
- Assess the frequency and severity of toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Antioch, California, 미국, 94531
- Kaiser Permanente - Deer Valley
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Berkeley, California, 미국, 94704
- Alta Bates Summit Comprehensive Cancer Center
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Burlingame, California, 미국, 94010
- Peninsula Medical Center
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Fremont, California, 미국, 94538
- Kaiser Permanente - Fremont
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Hayward, California, 미국, 94545
- Kaiser Permanente Medical Center - Hayward
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Marysville, California, 미국, 95901
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP
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Oakland, California, 미국, 94611
- Kaiser Permanente Medical Center - Oakland
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Pleasanton, California, 미국, 94588
- Valley Medical Oncology Consultants - Pleasanton
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Redwood City, California, 미국, 94063
- Kaiser Permanente Medical Center - Redwood City
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Richmond, California, 미국, 94801
- Kaiser Permanente Medical Center - Richmond
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Roseville, California, 미국, 95661
- Kaiser Permanente Medical Center - Roseville
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Sacramento, California, 미국, 95817
- University of California Davis Cancer Center
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Sacramento, California, 미국, 95823
- South Sacramento Kaiser-Permanente Medical Center
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Sacramento, California, 미국, 95825
- Kaiser Permanente Medical Center - Sacramento
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San Francisco, California, 미국, 94115
- Kaiser Permanente Medical Center - San Francisco Geary Campus
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San Francisco, California, 미국, 94118
- California Pacific Medical Center - California Campus
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San Jose, California, 미국, 95119
- Kaiser Permanente Medical Center - Santa Teresa
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San Rafael, California, 미국, 94903
- Sutter Health - Western Division Cancer Research Group
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San Rafael, California, 미국, 94903
- Kaiser Foundation Hospital - San Rafael
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Santa Clara, California, 미국, 95051
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
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Santa Rosa, California, 미국, 95403
- Kaiser Permanente Medical Center - Santa Rosa
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South San Francisco, California, 미국, 94080
- Kaiser Permanente Medical Center - South San Francisco
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Stockton, California, 미국, 95210
- Kaiser Permanente Medical Facility - Stockton
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Truckee, California, 미국, 96161
- Tahoe Forest Cancer Center
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Vacaville, California, 미국, 95688
- Kaiser Permanente Medical Center - Vacaville
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Vallejo, California, 미국, 94589
- Sutter Solano Medical Center
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Vallejo, California, 미국, 94589
- Kaiser Permanente Medical Center - Vallejo
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Walnut Creek, California, 미국, 94596
- Kaiser Permanente Medical Center - Walnut Creek
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Connecticut
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Hartford, Connecticut, 미국, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Georgia
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Atlanta, Georgia, 미국, 30309
- Piedmont Hospital
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Atlanta, Georgia, 미국, 30342-1611
- Northside Hospital Cancer Center
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Atlanta, Georgia, 미국, 30342-1701
- Saint Joseph's Hospital of Atlanta
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Atlanta, Georgia, 미국, 30342
- CCOP - Atlanta Regional
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Austell, Georgia, 미국, 30106
- WellStar Cobb Hospital
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Columbus, Georgia, 미국, 31904
- John B. Amos Cancer Center
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Decatur, Georgia, 미국, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Fayetteville, Georgia, 미국, 30214
- Piedmont Fayette Hospital
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Gainesville, Georgia, 미국, 30501
- Northeast Georgia Medical Center
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Lawrenceville, Georgia, 미국, 30045
- Gwinnett Medical Center
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Marietta, Georgia, 미국, 30060
- Kennestone Cancer Center at Wellstar Kennestone Hospital
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Riverdale, Georgia, 미국, 30274-2600
- Southern Regional Medical Center
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Rome, Georgia, 미국, 30165
- Harbin Clinic Cancer Center - Medical Oncology
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Hawaii
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Honolulu, Hawaii, 미국, 96819
- Kaiser Permanente - Moanalua Medical Center and Clinic
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Illinois
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Decatur, Illinois, 미국, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Maywood, Illinois, 미국, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Springfield, Illinois, 미국, 62781-0001
- Regional Cancer Center at Memorial Medical Center
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Kansas
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Chanute, Kansas, 미국, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, 미국, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, 미국, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, 미국, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, 미국, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, 미국, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, 미국, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, 미국, 67901
- Cancer Center of Kansas, PA - Liberal
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Newton, Kansas, 미국, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, 미국, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, 미국, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, 미국, 67401
- Cancer Center of Kansas, PA - Salina
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Salina, Kansas, 미국, 67401
- Tammy Walker Cancer Center at Salina Regional Health Center
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Topeka, Kansas, 미국, 66606
- Cotton-O'Neil Cancer Center
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Wellington, Kansas, 미국, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, 미국, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, 미국, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, 미국, 67214
- CCOP - Wichita
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Wichita, Kansas, 미국, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, 미국, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, 미국, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Lexington, Kentucky, 미국, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Michigan
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Ann Arbor, Michigan, 미국, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, 미국, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, 미국, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, 미국, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, 미국, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, 미국, 48503
- Hurley Medical Center
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Flint, Michigan, 미국, 48503
- Genesys Hurley Cancer Institute
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Grand Blanc, Michigan, 미국, 48439
- Genesys Regional Medical Center
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Grand Rapids, Michigan, 미국, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, 미국, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, 미국, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, 미국, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, 미국, 49201
- Foote Memorial Hospital
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Lansing, Michigan, 미국, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, 미국, 48154
- St. Mary Mercy Hospital
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Muskegon, Michigan, 미국, 49443
- Mercy General Health Partners
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Pontiac, Michigan, 미국, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, 미국, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, 미국, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Traverse City, Michigan, 미국, 49684
- Munson Medical Center
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Warren, Michigan, 미국, 48093
- St. John Macomb Hospital
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Wyoming, Michigan, 미국, 49519
- Metro Health Hospital
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Montana
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Billings, Montana, 미국, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, 미국, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, 미국, 59107-7000
- Billings Clinic - Downtown
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Billings, Montana, 미국, 59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Bozeman, Montana, 미국, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, 미국, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, 미국, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, 미국, 59405-5309
- Big Sky Oncology
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Great Falls, Montana, 미국, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Havre, Montana, 미국, 59501
- Northern Montana Hospital
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Helena, Montana, 미국, 59601
- St. Peter's Hospital
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Kalispell, Montana, 미국, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, 미국, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, 미국, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, 미국, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, 미국, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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North Carolina
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Goldsboro, North Carolina, 미국, 27534
- Wayne Memorial Hospital, Incorporated
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Hendersonville, North Carolina, 미국, 28791
- Pardee Memorial Hospital
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Ohio
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Bellefontaine, Ohio, 미국, 43311
- Mary Rutan Hospital
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Chillicothe, Ohio, 미국, 45601
- Adena Regional Medical Center
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Columbus, Ohio, 미국, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, 미국, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, 미국, 43215
- CCOP - Columbus
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Columbus, Ohio, 미국, 43215
- Grant Medical Center Cancer Care
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Columbus, Ohio, 미국, 43228
- Doctors Hospital at Ohio Health
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Delaware, Ohio, 미국, 43015
- Grady Memorial Hospital
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Lancaster, Ohio, 미국, 43130
- Fairfield Medical Center
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Marietta, Ohio, 미국, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Mount Vernon, Ohio, 미국, 43050
- Knox Community Hospital
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Newark, Ohio, 미국, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Springfield, Ohio, 미국, 45505
- Community Hospital of Springfield and Clark County
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Westerville, Ohio, 미국, 43081
- Mount Carmel St. Ann's Cancer Center
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Zanesville, Ohio, 미국, 43701
- Genesis - Good Samaritan Hospital
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Utah
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American Fork, Utah, 미국, 84003
- American Fork Hospital
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Cedar City, Utah, 미국, 84720
- Sandra L. Maxwell Cancer Center
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Logan, Utah, 미국, 84321
- Logan Regional Hospital
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Murray, Utah, 미국, 84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
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Ogden, Utah, 미국, 84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
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Provo, Utah, 미국, 84604
- Utah Valley Regional Medical Center - Provo
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Saint George, Utah, 미국, 84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City, Utah, 미국, 84143
- LDS Hospital
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Salt Lake City, Utah, 미국, 84106
- Utah Cancer Specialists at UCS Cancer Center
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Washington
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Bellingham, Washington, 미국, 98225
- St. Joseph Cancer Center
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Bremerton, Washington, 미국, 98310
- Olympic Hematology and Oncology
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Kennewick, Washington, 미국, 99336
- Columbia Basin Hematology
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Mount Vernon, Washington, 미국, 98274
- Skagit Valley Hospital Cancer Care Center
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Poulsbo, Washington, 미국, 98370
- Harrison Poulsbo Hematology and Onocology
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Seattle, Washington, 미국, 98109
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, 미국, 98104
- Harborview Medical Center
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Seattle, Washington, 미국, 98104
- Minor and James Medical, PLLC
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Seattle, Washington, 미국, 98112
- Group Health Central Hospital
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Seattle, Washington, 미국, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Seattle, Washington, 미국, 98195
- University Cancer Center at University of Washington Medical Center
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Spokane, Washington, 미국, 99202
- Cancer Care Northwest - Spokane South
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Spokane, Washington, 미국, 99218
- Evergreen Hematology and Oncology, PS
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Wenatchee, Washington, 미국, 98801-2028
- Wenatchee Valley Medical Center
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Wyoming
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Sheridan, Wyoming, 미국, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Biopsy-proven* bronchioloalveolar carcinoma (BAC) or BAC variants (e.g., adenocarcinoma with BAC features, BAC with invasive adenocarcinoma) meeting the following criteria:
- Incompletely resected or unresectable disease
- No component of squamous cell carcinoma
Disease staged as 1 of the following:
- Stage IIIB disease (T4 [cytologically confirmed malignant pleural effusion OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor], any N, M0)
Stage IV disease (any T, any N, M1 [distant metastases present])
- Recurrent disease in a separate lobe after prior resection within the past 5 years; multifocal lesions in > 1 lobe; or any disease that is recurrent after surgery or radiotherapy is considered stage IV disease
- Tumor may be multifocal or diffuse NOTE: *Cytology specimens, including bronchial brushing, washings, or fine needle aspiration specimens, alone are not acceptable for diagnosis
Measurable or nonmeasurable disease by chest CT scan
- Pleural effusions, ascites, and laboratory parameters are not acceptable as only evidence of disease
- Disease must be present outside field of prior radiotherapy OR a new lesion must be inside port
- Treated brain metastases allowed provided the patient is asymptomatic and do not require steroids
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin normal
- AST or AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases are present)
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
- Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1 g by 24-hour urine collection
- Willing to provide prior smoking history
- No hemoptysis ≥ ½ teaspoon within the past 28 days
- No clinical history of pulmonary or upper respiratory hemorrhage > grade 2 within the past 6 months or > grade 1 within the past 28 days
- No history of thromboses or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding
- No uncontrolled hypertension
- No serious nonhealing wound, ulcer, or bone fracture
No other prior malignancy except for any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer that is currently in complete remission
- Any other cancer from which the patient has been disease free for 5 years
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- At least 28 days since prior radiotherapy (14 days for palliative radiotherapy)
- At least 28 days since prior surgery (thoracic or other major surgeries)
- More than 7 days since prior fine-needle aspiration or core biopsy
- At least 28 days since prior systemic chemotherapy or biologic therapy
- No prior gefitinib hydrochloride, erlotinib hydrochloride, or bevacizumab
- No other prior anti-epidermal growth factor receptor or anti-vascular endothelial growth factor therapies
- Concurrent stable, therapeutic anticoagulation therapy allowed (i.e., warfarin or low molecular weight heparin), provided the patient has no history of bleeding complications on anticoagulation or an inability to establish a stable therapeutic regimen for anticoagulation
- No other concurrent anticancer therapy, including surgery, chemotherapy, hormone therapy, biologic therapy, or radiotherapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Erlotinib and Bevacizumab
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Overall Survival
기간: From date of registration to maximum of 3 years
|
From date of registration to maximum of 3 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-free Survival
기간: From date of registration to maximum of 3 years
|
From date of registration to maximum of 3 years
|
|
|
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease
기간: From date of registration to maximum of 3 years
|
Images for response assessed by the central computer-assisted image-analysis system were never collected.
|
From date of registration to maximum of 3 years
|
|
Frequency and Severity of Toxicities
기간: From date of registration to maximum of 3 years
|
From date of registration to maximum of 3 years
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- West HJ, Moon J, Hirsch FR, et al.: SWOG S0635 and S0636: Phase II trials in advanced-stage NSCLC of erlotinib (OSI-774) and bevacizumab in bronchioloalveolar carcinoma (BAC) and adenocarcinoma with BAC features (adenoBAC), and in never-smokers with primary NSCLC adenocarcinoma (adenoCa). [Abstract] J Clin Oncol 30 (Suppl 15): A-7517, 2012.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000529756
- U10CA032102 (미국 NIH 보조금/계약)
- S0635 (기타 식별자: SWOG)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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SB Istanbul Education and Research Hospital아직 모집하지 않음Thryoid cancer | parathyrıoid 선종
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Jonsson Comprehensive Cancer CenterNovartis Pharmaceuticals모병전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer Center모병전립선 선암종 | 2기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Taichung Veterans General Hospital완전한심장 독성 | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung) | 의약품 관련 부작용 및 이상반응 (MeSH 용어) | Egfr 티로신 키나아제 억제제대만
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Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Society for Endocrinology초대로 등록
베바시주맙에 대한 임상 시험
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Shanghai Pudong HospitalShanghai Junshi Bioscience Co., Ltd.아직 모집하지 않음
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Assistance Publique - Hôpitaux de Paris아직 모집하지 않음BCLC 단계 B 또는 C로 분류 된 고급 간세포 암종 (HCC)은 선택적 내부 방사선 요법의 조합으로 치료됩니다.프랑스
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Yonsei University모병암종 | 간 신생물 | 간세포 암 | 간세포대한민국
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Sun Yat-sen UniversityQilu Pharmaceutical Co., Ltd.모집하지 않고 적극적으로간세포 암종(HCC) | 2차 치료중국
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University of Utah빼는
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Shanghai Chest HospitalInnovent Biologics (Suzhou) Co. Ltd.아직 모집하지 않음PD-L1 양성 | EGFR 돌연변이 양성 진행성 비소세포폐암
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National Center for Tumor Diseases, HeidelbergPfizer; Roche Pharma AG종료됨