A Randomized Phase II Study to Determine the Effect of 2 Different Doses AVE0005 (VEGF Trap) in Patients With Metastatic Renal Cell Carcinoma
PRIMARY OBJECTIVES:
I. Compare the effect of two different doses of AVE0005 (vascular endothelial growth factor
[VEGF] Trap) 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. 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. Describe progression-free survival among patients who undergo dose escalation after
progression on low-dose AVE0005 (VEGF Trap).
III. Evaluate the safety and tolerability of AVE0005 (VEGF Trap) in patients with
metastatic renal cell carcinoma who have had previous treatment with a TKI.
IV. Determine the circulating levels of VEGF AVE0005 (VEGF-Trap) complex and correlate it
with clinical activity.
V. Evaluate the modulation of specific angiogenesis-related protein expression by AVE0005
(VEGF Trap).
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
cytokine therapy (yes vs no) and Memorial Sloan Kettering Cancer Center (MSKCC) risk (low vs
medium vs high). Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive a higher dose of VEGF Trap intervenously (IV) over 1 hour on day 1.
ARM B: Patients receive a lower dose of VEGF Trap 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 I may crossover and receive
treatment on arm II if disease progression is evident after 4 courses of treatment.
After completion of study treatment, patients are followed every 3 months for 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
A two-stage design will be used within each arm.
Time from randomization to the earlier of documentation of progression or death, assessed at 8 weeks
No
Roberto Pili
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2009-00559
NCT00357760
December 2007
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Hurley Medical Center | Flint, Michigan 48503 |
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 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Beth Israel Medical Center | New York, New York 10003 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Scott and White Memorial Hospital | Temple, Texas 76508 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Sibley Memorial Hospital | Washington, District of Columbia 20016 |
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 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Eureka Hospital | Eureka, Illinois 61530 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Graham Hospital Association | Canton, Illinois 61520 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Pekin Hospital | Pekin, Illinois 61554 |
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 |
Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Swedish American Hospital | Rockford, Illinois 61104 |
Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
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 |
UW Cancer Center Johnson Creek | Johnson Creek, Wisconsin 53038 |
Longmont United Hospital | Longmont, Colorado 80501 |
Manchester Memorial Hospital | Manchester, Connecticut 06040-4188 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
Hennepin County Medical Center | Minneapolis, Minnesota |
University of Florida | Gainesville, Florida 32610-0277 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Emory University | Atlanta, Georgia 30322 |
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 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
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 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Littleton Adventist Hospital | Littleton, Colorado 80122 |
Parker Adventist Hospital | Parker, Colorado 80138 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
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 |
Saint Joseph's-Candler Health System | Savannah, Georgia 31405 |
Rush - Copley Medical Center | Aurora, Illinois 60504 |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Saint Margaret's Hospital | Spring Valley, Illinois 61362 |
Carle Clinic-Urbana Main | Urbana, Illinois 61801 |
Wishard Hospital | Indianapolis, Indiana 46202 |
Saint Anthony Memorial Health Center | Michigan City, Indiana 46360 |
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 - North Iowa | Mason City, Iowa 50401 |
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 |
Lincoln Medical Education Foundation Cancer Resource Center | Lincoln, Nebraska 68510 |
Missouri Valley Cancer Consortium CCOP | Omaha, Nebraska 68106 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Veterans Adminstration New Jersey Health Care System | East Orange, New Jersey 07018-1095 |
The North Division of Montefiore Medical Center | Bronx, New York 10466 |
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 |
Natalie W Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Saint Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Mainline Health CCOP | Wynnewood, Pennsylvania 19096 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Dean Hematology and Oncology Clinic | Madison, Wisconsin 53717 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
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 |
West Virginia University Charleston | Charleston, West Virginia 25304 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Hinsdale Hematology Oncology Associates Incorporated | Hinsdale, Illinois 60521 |
Southern Ohio Medical Center | Portsmouth, Ohio 45662 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
Saint Nicholas Hospital | Madison, Wisconsin 53715 |
Alegent Health Lakeside Hospital | Omaha, Nebraska 68130 |
New York Oncology Hematology PC -Albany Medical Center | Albany, New York 12208 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
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 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 |
Lake Region Healthcare Corporation-Cancer Care | Fergus Falls, Minnesota 56537 |
Nevada Cancer Institute-Summerlin Campus | Las Vegas, Nevada 89135 |
Cancer Center of Western Wisconsin | New Richmond, Wisconsin 54017 |