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)
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.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Proportion of progression-free patients at 3 months
No
Alex A. Adjei, MD, PhD
Study Chair
Roswell Park Cancer Institute
United States: Federal Government
CDR0000456427
NCT00268489
May 2006
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Foote Hospital | Jackson, Michigan 49201 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
Southwest Medical Center | Liberal, Kansas 67901 |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
St. James Community Hospital | Butte, Montana 59701 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grant Riverside Cancer Services | Columbus, Ohio 43215 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Eden Medical Center | Castro Valley, California 94546 |
Saint Rose Hospital | Hayward, California 94545 |
Highland General Hospital at St. George's University School of Medicine | Oakland, California 94602 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Valley Care Medical Center | Pleasanton, California 94588 |
Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
Piedmont Hospital | Atlanta, Georgia 30309 |
WellStar Cobb Hospital | Austell, Georgia 30106 |
Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Reid Hospital & Health Care Services, Incorporated | Richmond, Indiana 47374 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
Alexandria, Minnesota 56308 | |
MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Chippewa County - Montevideo Hospital | Montevideo, Minnesota 56265 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Adirondack Cancer Care - Glens Falls | Glens Falls, New York 12801 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Cancer Care Center at Medcenter One Hospital | Bismarck, North Dakota 58501 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center | Bismarck, North Dakota 58502 |
MeritCare Medical Group | Fargo, North Dakota 58122 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
Mercy Medical Center | Springfield, Ohio 45504 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon 97210 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
Franciscan Skemp Healthcare | La Crosse, Wisconsin 54601-4796 |
Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta, Georgia 31603 |
Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Saint Francis Cancer Center | Shakopee, Minnesota 55379 |
St. Joseph's Hospital | St Paul, Minnesota 55102 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Randolph Hospital | Asheboro, North Carolina 27203 |
Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
Annie Penn Cancer Center | Reidsville, North Carolina 27320 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Salem Hospital Regional Cancer Care Services | Salem, Oregon 97309-5014 |
Guthrie Cancer Center at Guthrie Clinic Sayre | Sayre, Pennsylvania 18840 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Providence Cancer Center | Anchorage, Alaska 99508 |
Arch Medical Services, Incorporated at Center for Cancer Care Research | Saint Louis, Missouri 63141 |
Billings Clinic Cancer Center | Billings, Montana 59107-5100 |
Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
United States Air Force Medical Center - Wright-Patterson | Wright-Patterson AFB, Ohio 45433-5529 |
Ted B. Wahby Cancer Center at Mount Clemens General Hospital | Mount Clemens, Michigan 48043 |
Minnesota Oncology Hematology, PA at Maplewood Cancer Center | Maplewood, Minnesota 55109 |