Spots Global Cancer Trial Database for Ziv-Aflibercept in Treating Patients With Metastatic or Unresectable Kidney Cancer
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Trial Identification
Brief Title: Ziv-Aflibercept in Treating Patients With Metastatic or Unresectable Kidney Cancer
Official Title: A Randomized Phase II Study to Determine the Effect of 2 Different Doses of AVE0005 (VEGF Trap) in Patients With Metastatic Renal Cell Carcinoma
Study ID: NCT00357760
Conditions
Interventions
Study Description
Brief Summary: This randomized phase II trial studies how well ziv-aflibercept (VEGF Trap) works in treating patients with kidney cancer that has spread from the primary site to other places in the body (metastatic) or is unable to be removed with surgery (unresectable). Ziv-aflibercept may stop the growth of kidney cancer by blocking blood flow to the tumor.
Detailed Description: PRIMARY OBJECTIVE: I. To determine the effect of two different doses of AVE0005 (vascular endothelial growth factor \[VEGF\] Trap \[ziv-aflibercept\]) treatment on the progression-free proportion at 8 weeks in patients with metastatic renal cell carcinoma who had previous treatment with a tyrosine kinase inhibitor (TKI). SECONDARY OBJECTIVES: I. To determine the effect of AVE0005 (VEGF Trap) treatment on objective response rate in patients with metastatic renal cell carcinoma who have had previous TKI treatment. II. To describe progression-free survival among patients who undergo dose escalation following progression on low-dose AVE0005 (VEGF Trap). III. To evaluate the safety and tolerability of AVE0005 (VEGF Trap) in patients with metastatic renal cell carcinoma who have had previous treatment with a TKI. OTHER PRE-SPECIFIED OBJECTIVES: I. To determine the circulating levels of VEGF AVE0005 (VEGF-Trap) complex and correlate it with clinical activity. II. To evaluate the modulation of specific angiogenesis-related protein expression by AVE0005 (VEGF Trap). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A (Higher dose of VEGF Trap): Patients receive a higher dose of ziv-aflibercept intervenously (IV) over 1 hour on day 1. ARM B (Lower dose of VEGF Trap): Patients receive a lower dose of ziv-aflibercept IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients receiving treatment on Arm B may crossover and receive treatment on Arm A at the time of disease progression. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.
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
Parker Adventist Hospital, Parker, 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
Manchester Memorial Hospital, Manchester, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, United States
Sibley Memorial Hospital, Washington, D.C., District of Columbia, United States
University of Florida, Gainesville, Florida, United States
Emory University/Winship Cancer Institute, Atlanta, Georgia, 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
Rush - Copley Medical Center, Aurora, Illinois, United States
Saint Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital Association, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Heartland Cancer Research NCORP, Decatur, Illinois, United States
Eureka Hospital, Eureka, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Illinois CancerCare-Galesburg Cottage Plaza Office, Galesburg, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hinsdale Hematology Oncology Associates Incorporated, Hinsdale, Illinois, United States
Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, United States
Mcdonough District Hospital, Macomb, Illinois, United States
Bromenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center Foundation, Normal, Illinois, United States
Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, United States
Pekin Hospital, Pekin, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois Valley Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
SwedishAmerican Regional Cancer Center/ACT, Rockford, Illinois, United States
Saint Margaret's Hospital, Spring Valley, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana, United States
Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, 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
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
Mercy Medical Center - North Iowa, Mason City, 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 - Wichita, 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
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States
Beaumont Hospital-Dearborn, 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
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
Lake Region Healthcare Corporation-Cancer Care, Fergus Falls, 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
Nebraska Cancer Research Center, Lincoln, Nebraska, United States
Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States
Alegent Health Lakeside Hospital, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, United States
Nevada Cancer Institute-Summerlin Campus, Las Vegas, Nevada, United States
Veterans Adminstration New Jersey Health Care System, East Orange, New Jersey, United States
Rutgers New Jersey Medical School, Newark, New Jersey, United States
New York Oncology Hematology PC -Albany Medical Center, Albany, New York, United States
Mary Imogene Bassett Hospital, Cooperstown, New York, United States
Beth Israel Medical Center, New York, New York, United States
Montefiore Medical Center-Wakefield Campus, The Bronx, New York, 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
Strecker Cancer Center-Belpre, Belpre, Ohio, United States
Aultman Health Foundation, Canton, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Columbus Oncology and Hematology Associates Inc, Columbus, 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
Delaware Health Center-Grady Cancer Center, Delaware, 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
Trinity's Tony Teramana Cancer Center, Steubenville, Ohio, United States
Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States
Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa, Oklahoma, United States
Saint Luke's University Hospital-Bethlehem Campus, Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Geisinger Medical Group, State College, 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
Scott and White Memorial Hospital, Temple, Texas, United States
West Virginia University Charleston, Charleston, West Virginia, United States
Saint Vincent Hospital, Green Bay, Wisconsin, United States
UW Cancer Center Johnson Creek, Johnson Creek, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Dean Hematology and Oncology Clinic, Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Saint Nicholas Hospital, Sheboygan, Wisconsin, United States
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
Contact Details
Name: Roberto Pili
Affiliation: ECOG-ACRIN Cancer Research Group
Role: PRINCIPAL_INVESTIGATOR
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