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Brief Title: Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title: 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)
Study ID: NCT00268489
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Providence Cancer Center, Anchorage, Alaska, United States
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Eden Medical Center, Castro Valley, California, United States
Saint Rose Hospital, Hayward, California, United States
Highland General Hospital at St. George's University School of Medicine, Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
Valley Care Medical Center, Pleasanton, California, United States
Doctors Medical Center - San Pablo Campus, San Pablo, California, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Piedmont Hospital, Atlanta, Georgia, United States
Northside Hospital Cancer Center, Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta, Atlanta, Georgia, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
WellStar Cobb Hospital, Austell, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center, Decatur, Georgia, United States
Gwinnett Medical Center, Lawrenceville, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital, Marietta, Georgia, United States
Southern Regional Medical Center, Riverdale, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center, Valdosta, Georgia, United States
Saint Anthony's Hospital at Saint Anthony's Health Center, Alton, Illinois, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Galesburg Clinic, Galesburg, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hopedale Medical Complex, Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
McDonough District Hospital, Macomb, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Good Samaritan Regional Health Center, Mt. Vernon, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
St. Margaret's Hospital, Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
Reid Hospital & Health Care Services, Incorporated, Richmond, Indiana, United States
McFarland Clinic, PC, Ames, Iowa, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
Genesis Regional Cancer Center at Genesis Medical Center, Davenport, Iowa, United States
Mercy Capitol Hospital, Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association, 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
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City, Iowa, United States
McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Southwest Medical Center, Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Green Bay Oncology, Limited - Iron Mountain, Iron Mountain, Michigan, United States
Foote Hospital, Jackson, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
Ted B. Wahby Cancer Center at Mount Clemens General Hospital, Mount Clemens, Michigan, United States
Seton Cancer Institute - Saginaw, Saginaw, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
, Alexandria, Minnesota, United States
MeritCare Clinic - Bemidji, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller-Dwan Medical Center, Duluth, Minnesota, United States
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
, Fergus Falls, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Meeker County Memorial Hospital, Lichfield, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Minnesota Oncology Hematology, PA at Maplewood Cancer Center, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
Chippewa County - Montevideo Hospital, Montevideo, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Coborn Cancer Center, Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Saint Francis Cancer Center, Shakopee, Minnesota, United States
St. Joseph's Hospital, St Paul, Minnesota, United States
CentraCare Clinic - River Campus, St. Cloud, Minnesota, United States
Park Nicollet Health Services, St. Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center, St. Paul, Minnesota, United States
United Hospital, St. Paul, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States
Woodwinds Health Campus, Woodbury, Minnesota, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Gape Girardeau, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Arch Medical Services, Incorporated at Center for Cancer Care Research, Saint Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
Missouri Baptist Cancer Center, St. Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, St. Louis, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
St. Vincent Healthcare, Billings, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Deaconess Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
St. James Community Hospital, Butte, Montana, United States
Big Sky Oncology, Great Falls, Montana, United States
Sletten Regional Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Center, Missoula, Montana, United States
Guardian Oncology and Center for Wellness, Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital, Kearney, Nebraska, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Adirondack Cancer Care - Glens Falls, Glens Falls, New York, United States
Randolph Hospital, Asheboro, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina, United States
Pardee Memorial Hospital, Hendersonville, North Carolina, United States
Annie Penn Cancer Center, Reidsville, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Iredell Memorial Hospital, Statesville, North Carolina, United States
Bismarck Cancer Center, Bismarck, North Dakota, United States
Cancer Care Center at Medcenter One Hospital, Bismarck, North Dakota, United States
Mid Dakota Clinic, PC, Bismarck, North Dakota, United States
St. Alexius Medical Center, Bismarck, North Dakota, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
MeritCare Medical Group, Fargo, North Dakota, United States
Altru Cancer Center at Altru Hospital, Grand Forks, North Dakota, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Riverside Cancer Services, Columbus, Ohio, United States
Mount Carmel Health - West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital, Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Middletown Regional Hospital, Middletown, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
Mercy Medical Center, Springfield, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital, Westerville, Ohio, United States
United States Air Force Medical Center - Wright-Patterson, Wright-Patterson Afb, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center, Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital, Portland, Oregon, United States
Salem Hospital Regional Cancer Care Services, Salem, Oregon, United States
Legacy Meridian Park Hospital, Tualatin, Oregon, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania, United States
Guthrie Cancer Center at Guthrie Clinic Sayre, Sayre, Pennsylvania, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
M.D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Danville Regional Medical Center, Danville, Virginia, United States
St. Joseph Cancer Center, Bellingham, Washington, United States
Olympic Hematology and Oncology, Bremerton, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Minor and James Medical, PLLC, Seattle, Washington, United States
Group Health Central Hospital, Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States
Polyclinic First Hill, Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
Wenatchee Valley Medical Center, Wenatchee, Washington, United States
Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, 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
Franciscan Skemp Healthcare, La Crosse, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Name: Alex A. Adjei, MD, PhD
Affiliation: Roswell Park Cancer Institute
Role: STUDY_CHAIR