A Phase II Randomized Trial of Paclitaxel, Carboplatin, Bevacizumab With or Without IMC-A12 in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
PRIMARY OBJECTIVES:
I. To evaluate the progression-free survival with the combination of carboplatin,
paclitaxel, and bevacizumab with vs without cixutumumab in patients with stage IV or
recurrent non-squamous, non-small cell lung cancer.
SECONDARY OBJECTIVES:
I. To evaluate overall survival and response rate of the above combination in patients with
non-squamous, advanced non-small cell lung cancer.
II. To evaluate the toxicities of the above combination in patients with non-squamous
advanced non-small cell lung cancer.
OUTLINE: Patients are stratified according to ECOG performance status (0 vs 1). Patients are
randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours, carboplatin IV over 30
minutes, and bevacizumab IV over 30-90 minutes on day 1.
ARM II: Patients receive paclitaxel, carboplatin, and bevacizumab as in arm I. Patients also
receive cixutumumab IV over 1 hour on days 1, 8, and 15.In both arms, treatment repeats
every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment with bevacizumab and cixutumumab may continue in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
From randomization to disease progression or death from any cause, up to 5 years
No
Athanassios Argiris
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2011-01960
NCT00955305
March 2010
Name | Location |
---|---|
Hurley Medical Center | Flint, Michigan 48503 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Mercy Medical Center | Springfield, Ohio 45504 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Ottumwa Regional Health Center | Ottumwa, Iowa 52501 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Fox Valley Hematology and Oncology | Appleton, Wisconsin 54911 |
Swedish American Hospital | Rockford, Illinois 61104 |
Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
Saint Joseph Hospital | Chicago, Illinois 60657 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Longmont United Hospital | Longmont, Colorado 80501 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Albert Einstein Medical Center | Philadelphia, Pennsylvania 19141 |
Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Cancer Center of Kansas - McPherson | McPherson, Kansas 67460 |
Columbus CCOP | Columbus, Ohio 43206 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Alegent Health Immanuel Medical Center | Omaha, Nebraska 68122 |
Alegent Health Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Tufts Medical Center | Boston, Massachusetts 02111 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Littleton Adventist Hospital | Littleton, Colorado 80122 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
Froedtert and the Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
The Medical Center of Aurora | Aurora, Colorado 80012 |
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado 80907 |
Saint Anthony Central Hospital | Denver, Colorado 80204 |
Exempla Saint Joseph Hospital | Denver, Colorado 80218 |
Colorado Cancer Research Program CCOP | Denver, Colorado 80224-2522 |
Saint Mary's Hospital and Regional Medical Center | Grand Junction, Colorado 81502 |
Saint Mary Corwin Medical Center | Pueblo, Colorado 81004 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
McFarland Clinic | Ames, Iowa 50010 |
Cedar Rapids Oncology Association | Cedar Rapids, Iowa 52403 |
Mercy Hospital | Cedar Rapids, Iowa 52403 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Miller-Dwan Hospital | Duluth, Minnesota 55805 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Missouri Valley Cancer Consortium CCOP | Omaha, Nebraska 68106 |
Hunterdon Medical Center | Flemington, New Jersey 08822 |
Aultman Health Foundation | Canton, Ohio 44710 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Saint Rita's Medical Center | Lima, Ohio 45801 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
Pottstown Memorial Medical Center | Pottstown, Pennsylvania 19464 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Mainline Health CCOP | Wynnewood, Pennsylvania 19096 |
Dean Hematology and Oncology Clinic | Madison, Wisconsin 53717 |
Marshfield Clinic-Minocqua Center | Minocqua, Wisconsin 54548 |
Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc, Wisconsin 53066-3896 |
Marshfield Clinic at James Beck Cancer Center | Rhinelander, Wisconsin 54501 |
Marshfield Clinic-Rice Lake Center | Rice Lake, Wisconsin 54868 |
Marshfield Clinic-Wausau Center | Wausau, Wisconsin 54401 |
Roger Maris Cancer Center | Fargo, North Dakota 58122 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
UMDNJ - New Jersey Medical School | Newark, New Jersey 07103 |
Saint Mary Medical and Regional Cancer Center | Langhorne, Pennsylvania 19047 |
West Virginia University Charleston | Charleston, West Virginia 25304 |
Marshfield Clinic-Chippewa Center | Chippewa Falls, Wisconsin 54729 |
Marshfield Clinic Cancer Care at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Connecticut Oncology and Hematology LLP | Torrington, Connecticut 06790 |
Hinsdale Hematology Oncology Associates Incorporated | Hinsdale, Illinois 60521 |
The Christ Hospital | Cincinnati, Ohio 45219 |
Southern Ohio Medical Center | Portsmouth, Ohio 45662 |
Dallas VA Medical Center | Dallas, Texas 75216 |
Alegent Health Lakeside Hospital | Omaha, Nebraska 68130 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Oncology Associates at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
Sanford Clinic North-Fargo | Fargo, North Dakota 58102 |
Sanford Medical Center-Fargo | Fargo, North Dakota 58122 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Sanford Clinic North-Bemidgi | Bemidji, Minnesota 56601 |
Essentia Health Saint Joseph's Medical Center | Brainerd, Minnesota 56401 |
Essentia Health Duluth Clinic CCOP | Duluth, Minnesota 55805 |
Essentia Health Saint Mary's Medical Center | Duluth, Minnesota 55805 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
PinnacleHealth Fox Chase Regional Cancer Center at Polyclinic Hospital | Harrisburg, Pennsylvania 17110 |