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Spots Global Cancer Trial Database for Paclitaxel, Carboplatin, and Bevacizumab With or Without Cixutumumab in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer

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Trial Identification

Brief Title: Paclitaxel, Carboplatin, and Bevacizumab With or Without Cixutumumab in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer

Official Title: 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

Study ID: NCT00955305

Study Description

Brief Summary: This randomized phase II trial studies how well carboplatin, paclitaxel, and bevacizumab (CPB) work when given with or without cixutumumab in treating patients with non-small cell lung cancer that is stage IV or has come back (recurrent). Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Other types of monoclonal antibodies, such as cixutumumab, may find tumor cells and help kill them. It is not yet known whether giving more than one drug (combination chemotherapy) together with bevacizumab is more effective when given with or without cixutumumab in treating patients with non-small cell lung cancer.

Detailed Description: PRIMARY OBJECTIVES: I. To evaluate the progression-free survival with the combination of carboplatin, paclitaxel, and bevacizumab, and +/- IMC-A12 (cixutumumab) in patients with advanced, 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 randomized to 1 of 2 treatment arms. ARM A (CPB): Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. ARM B (CPB+cixutumumab): Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The Medical Center of Aurora, Aurora, Colorado, United States

Boulder Community Hospital, Boulder, Colorado, United States

Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States

Porter Adventist Hospital, Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States

SCL Health Saint Joseph Hospital, Denver, Colorado, United States

Rose Medical Center, Denver, Colorado, United States

Colorado Cancer Research Program NCORP, Denver, Colorado, United States

Swedish Medical Center, Englewood, Colorado, United States

Saint Mary's Hospital and Regional Medical Center, Grand Junction, Colorado, United States

North Colorado Medical Center, Greeley, Colorado, United States

Saint Anthony Hospital, Lakewood, Colorado, United States

Littleton Adventist Hospital, Littleton, Colorado, United States

Sky Ridge Medical Center, Lone Tree, Colorado, United States

Longmont United Hospital, Longmont, Colorado, United States

McKee Medical Center, Loveland, Colorado, United States

Saint Mary Corwin Medical Center, Pueblo, Colorado, United States

North Suburban Medical Center, Thornton, Colorado, United States

SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States

The Hospital of Central Connecticut, New Britain, Connecticut, United States

Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, United States

Charlotte Hungerford Hospital Center for Cancer Care, Torrington, Connecticut, United States

Lakeland Regional Cancer Center, Lakeland, Florida, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States

Saint Joseph Hospital, Chicago, Illinois, United States

Ingalls Memorial Hospital, Harvey, Illinois, United States

Hinsdale Hematology Oncology Associates Incorporated, Hinsdale, Illinois, United States

Swedish American Hospital, Rockford, Illinois, United States

SwedishAmerican Regional Cancer Center/ACT, Rockford, Illinois, United States

McFarland Clinic PC-William R Bliss Cancer Center, Ames, Iowa, United States

Mercy Hospital, Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States

Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, United States

Mercy Cancer Center-West Lakes, Clive, Iowa, United States

Iowa Methodist Medical Center, Des Moines, Iowa, United States

Iowa-Wide Oncology Research Coalition NCORP, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States

Mercy Medical Center - Des Moines, Des Moines, Iowa, United States

Iowa Lutheran Hospital, Des Moines, Iowa, United States

Ottumwa Regional Health Center, Ottumwa, Iowa, United States

Siouxland Regional Cancer Center, Sioux City, Iowa, United States

Mercy Medical Center-Sioux City, Sioux City, Iowa, United States

Saint Luke's Regional Medical Center, Sioux City, Iowa, United States

Cancer Center of Kansas - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence, Independence, Kansas, United States

Cancer Center of Kansas-Kingman, Kingman, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Cancer Center of Kansas-Liberal, Liberal, Kansas, United States

Cancer Center of Kansas - McPherson, McPherson, Kansas, United States

Cancer Center of Kansas - Newton, Newton, Kansas, United States

Cancer Center of Kansas - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas - Salina, Salina, Kansas, United States

Cancer Center of Kansas - Wellington, Wellington, Kansas, United States

Associates In Womens Health, Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States

Cancer Center of Kansas - Main Office, Wichita, Kansas, United States

Via Christi Regional Medical Center, Wichita, Kansas, United States

Wichita NCI Community Oncology Research Program, Wichita, Kansas, United States

Cancer Center of Kansas - Winfield, Winfield, Kansas, United States

Tufts Medical Center, Boston, Massachusetts, United States

Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States

Michigan Cancer Research Consortium CCOP, Ann Arbor, Michigan, United States

Oakwood Hospital and Medical Center, Dearborn, Michigan, United States

Saint John Hospital and Medical Center, Detroit, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, United States

Allegiance Health, Jackson, Michigan, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Sparrow Hospital, Lansing, Michigan, United States

Saint Mary Mercy Hospital, Livonia, Michigan, United States

Saint Joseph Mercy Oakland, Pontiac, Michigan, United States

Saint Joseph Mercy Port Huron, Port Huron, Michigan, United States

Saint Mary's of Michigan, Saginaw, Michigan, United States

Saint John Macomb-Oakland Hospital, Warren, Michigan, United States

Sanford Clinic North-Bemidgi, Bemidji, Minnesota, United States

Essentia Health Saint Joseph's Medical Center, Brainerd, Minnesota, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Mercy Hospital, Coon Rapids, Minnesota, United States

Essentia Health Cancer Center, Duluth, Minnesota, United States

Essentia Health Saint Mary's Medical Center, Duluth, Minnesota, United States

Miller-Dwan Hospital, Duluth, Minnesota, United States

Fairview-Southdale Hospital, Edina, Minnesota, United States

Unity Hospital, Fridley, Minnesota, United States

Hutchinson Area Health Care, Hutchinson, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States

Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Hennepin County Medical Center, Minneapolis, Minnesota, United States

New Ulm Medical Center, New Ulm, Minnesota, United States

North Memorial Medical Health Center, Robbinsdale, Minnesota, United States

Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

United Hospital, Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center, Shakopee, Minnesota, United States

Lakeview Hospital, Stillwater, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Rice Memorial Hospital, Willmar, Minnesota, United States

Minnesota Oncology and Hematology PA-Woodbury, Woodbury, Minnesota, United States

Alegent Health Lakeside Hospital, Omaha, Nebraska, United States

Veterans Adminstration New Jersey Health Care System, East Orange, New Jersey, United States

Hunterdon Medical Center, Flemington, New Jersey, United States

Rutgers New Jersey Medical School, Newark, New Jersey, United States

Roger Maris Cancer Center, Fargo, North Dakota, United States

Sanford Clinic North-Fargo, Fargo, North Dakota, United States

Sanford Medical Center-Fargo, Fargo, North Dakota, United States

Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States

Mary Rutan Hospital, Bellefontaine, Ohio, United States

Mercy Medical Center, Canton, Ohio, United States

Adena Regional Medical Center, Chillicothe, Ohio, United States

The Christ Hospital, Cincinnati, Ohio, United States

Case Western Reserve University, Cleveland, Ohio, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

Columbus NCI Community Oncology Research Program, Columbus, Ohio, United States

Grant Medical Center, Columbus, Ohio, United States

Mount Carmel Health Center West, Columbus, Ohio, United States

Doctors Hospital, Columbus, Ohio, United States

Grady Memorial Hospital, Delaware, Ohio, United States

Fairfield Medical Center, Lancaster, Ohio, United States

Saint Rita's Medical Center, Lima, Ohio, United States

Marietta Memorial Hospital, Marietta, Ohio, United States

Knox Community Hospital, Mount Vernon, Ohio, United States

Licking Memorial Hospital, Newark, Ohio, United States

Southern Ohio Medical Center, Portsmouth, Ohio, United States

Springfield Regional Medical Center, Springfield, Ohio, United States

Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

PinnacleHealth Cancer Center-Community Campus, Harrisburg, Pennsylvania, United States

Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States

Saint Mary Medical and Regional Cancer Center, Langhorne, Pennsylvania, United States

Paoli Memorial Hospital, Paoli, Pennsylvania, United States

University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States

Albert Einstein Medical Center, Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

Pottstown Memorial Medical Center, Pottstown, Pennsylvania, United States

Geisinger Medical Group, State College, Pennsylvania, United States

Reading Hospital, West Reading, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States

Lankenau Medical Center, Wynnewood, Pennsylvania, United States

Main Line Health NCORP, Wynnewood, Pennsylvania, United States

Avera Cancer Institute, Sioux Falls, South Dakota, United States

Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota, United States

Dallas VA Medical Center, Dallas, Texas, United States

Parkland Memorial Hospital, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

West Virginia University Charleston, Charleston, West Virginia, United States

Fox Valley Hematology and Oncology, Appleton, Wisconsin, United States

Marshfield Clinic Cancer Center at Sacred Heart, Eau Claire, Wisconsin, United States

Dean Hematology and Oncology Clinic, Madison, Wisconsin, United States

Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States

Oconomowoc Memorial Hospital-ProHealth Care Inc, Oconomowoc, Wisconsin, United States

Waukesha Memorial Hospital, Waukesha, Wisconsin, United States

Contact Details

Name: Athanassios (Ethan) Argiris

Affiliation: ECOG-ACRIN Cancer Research Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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