A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma
OBJECTIVES:
- Determine the 6-month progression-free survival rate, in terms of proportion of those
with measurable disease or bone metastases only, of patients with locally recurrent or
metastatic renal cell carcinoma treated with atrasentan (measurable disease stratum
closed to accrual as of 7/16/04).
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior
immunotherapy/biologic therapy (yes vs no) and characteristic of disease (measurable vs bone
metastases only) (measurable disease stratum closed to accrual as of 7/16/04).
Patients receive oral atrasentan once daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.
PROJECTED ACCRUAL: A total of 180 patients (90 per stratum [with or without prior therapy])
will be accrued for this study within 6 months (based on prior accrual, the bone metastases
only group [specifically patients who have received 1 prior therapy] is the only stratum
open for accrual).
Interventional
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 6 months
No
Michael A. Carducci, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
CDR0000069382
NCT00039429
May 2003
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
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 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
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 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Mercy Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Columbus | Columbus, Ohio 43206 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Medical Center of Central Georgia | Macon, Georgia 31201 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
St. Luke's Hospital Cancer Center | Bethlehem, Pennsylvania 18015 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston, West Virginia 25302 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Chester County Hospital | West Chester, Pennsylvania 19380 |
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 |
Siouxland Hematology-Oncology Associates | Sioux City, Iowa 51101 |
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 |
Mount Carmel West Hospital | Columbus, Ohio 43222 |
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 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
MBCCOP-Medical College of Georgia Cancer Center | Augusta, Georgia 30912-4000 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland, Florida 33805 |
Veterans Affairs Medical Center - Chicago Westside Hospital | Chicago, Illinois 60612 |
Hematology Oncology Associates - Skokie | Skokie, Illinois 60076 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Joan Karnell Cancer Center at Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
St. Mary-Corwin Regional Medical Center | Pueblo, Colorado 81004 |
Swedish Covenant Hospital | Chicago, Illinois 60625 |
Mercy Hospital and Medical Center | Chicago, Illinois 60616 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Midwest Center for Hematology/Oncology | Joliet, Illinois 60432 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
Trinity Medical Center - East | Moline, Illinois 61265 |
Northwest Medical Specialist, PC | Niles, Illinois 60714 |
Midwest Cancer Research Group, Incorporated | Skokie, Illinois 60077 |
Hematology/Oncology of the North Shore at Gross Point Medical Center | Skokie, Illinois 60076 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
McFarland Clinic, P. C. | Ames, Iowa 50010 |
St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
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 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Pennington Cancer Center at Baton Rouge General | Baton Rouge, Louisiana 70806 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70112 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Bryan LGH Medical Center West | Lincoln, Nebraska 68502 |
St. Elizabeth Regional Medical Center | Lincoln, Nebraska 68510 |
MeritCare Medical Group | Fargo, North Dakota 58122 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Fremont Memorial Hospital | Fremont, Ohio 43420 |
Lima Memorial Hospital | Lima, Ohio 45804 |
St. Luke's Hospital | Maumee, Ohio 43537 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
Firelands Regional Medical Center | Sandusky, Ohio 44870 |
Mercy Medical Center | Springfield, Ohio 45504 |
Promedica Cancer Center at Flower Hospital | Sylvania, Ohio 43560 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Dean Medical Center - Fish Hatchery | Madison, Wisconsin 53715 |
Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
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 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Guthrie Medical Center - Sayre | Sayre, Pennsylvania 18840 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
York Cancer Center at Wellspan Health | York, Pennsylvania 17403 |
PinnacleHealth Regional Cancer Center at Polyclinic Hospital | Harrisburg, Pennsylvania 17105 |
Cancer Care Institute of Carolina at Aiken Regional Medical Centers | Aiken, South Carolina 29801 |
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center | Boca Raton, Florida 33486 |
Veterans Affairs Medical Center - Augusta | Augusta, Georgia 30904 |
Elmhurst Memorial Hospital | Elmhurst, Illinois 60126 |
Northeast Georgia Cancer Care, LLC | Athens, Georgia 30607 |
Central Pennsylvania Hematology and Medical Oncology Associates, P. C. | Lemoyne, Pennsylvania 17043 |
All Saints Cancer Center at All Saints Medical Center | Racine, Wisconsin 53405 |