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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00039429 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: atrasentan hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma |
| Estimated Enrollment: | 180 |
| Study Start Date: | May 2003 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Progressive disease, defined by 1 of the following:
One of the following disease characteristics:
At least 1 measurable lesion (measurable disease stratum closed to accrual as of 7/16/04.)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No more than 1 prior regimen* of biologic therapy/immunotherapy (e.g., interleukin-2, interferon, thalidomide, or combination)
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, Colorado | |
| Aurora Presbyterian Hospital | |
| Aurora, Colorado, United States, 80012 | |
| Boulder Community Hospital | |
| Boulder, Colorado, United States, 80301-9019 | |
| CCOP - Colorado Cancer Research Program, Incorporated | |
| Denver, Colorado, United States, 80224-2522 | |
| Hope Cancer Care Center at Longmont United Hospital | |
| Longmont, Colorado, United States, 80502 | |
| Rose Medical Center | |
| Denver, Colorado, United States, 80220 | |
| Penrose Cancer Center at Penrose Hospital | |
| Colorado Springs, Colorado, United States, 80933 | |
| Porter Adventist Hospital | |
| Denver, Colorado, United States, 80210 | |
| Presbyterian - St. Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| North Suburban Medical Center | |
| Thorton, Colorado, United States, 80229 | |
| Sky Ridge Medical Center | |
| Lone Tree, Colorado, United States, 80124 | |
| St. Joseph Hospital | |
| Denver, Colorado, United States, 80218 | |
| St. Mary-Corwin Regional Medical Center | |
| Pueblo, Colorado, United States, 81004 | |
| Swedish Medical Center | |
| Englewood, Colorado, United States, 80110 | |
| United States, Florida | |
| Lakeland Regional Cancer Center at Lakeland Regional Medical Center | |
| Lakeland, Florida, United States, 33805 | |
| Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center | |
| Boca Raton, Florida, United States, 33486 | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Georgia | |
| MBCCOP-Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912 | |
| Medical Center of Central Georgia | |
| Macon, Georgia, United States, 31208 | |
| Northeast Georgia Cancer Care, LLC | |
| Athens, Georgia, United States, 30607 | |
| Veterans Affairs Medical Center - Augusta | |
| Augusta, Georgia, United States, 30904 | |
| United States, Illinois | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| Veterans Affairs Medical Center - Lakeside Chicago | |
| Chicago, Illinois, United States, 60611 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Elmhurst Memorial Hospital | |
| Elmhurst, Illinois, United States, 60126 | |
| Hematology and Oncology Associates | |
| Chicago, Illinois, United States, 60611 | |
| Hematology Oncology Associates - Skokie | |
| Skokie, Illinois, United States, 60076 | |
| Hematology/Oncology of the North Shore at Gross Point Medical Center | |
| Skokie, Illinois, United States, 60076 | |
| Hinsdale Hematology Oncology Associates | |
| Hinsdale, Illinois, United States, 60521 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Mercy Hospital and Medical Center | |
| Chicago, Illinois, United States, 60616 | |
| Midwest Cancer Research Group, Incorporated | |
| Skokie, Illinois, United States, 60077 | |
| Midwest Center for Hematology/Oncology | |
| Joliet, Illinois, United States, 60432 | |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | |
| Libertyville, Illinois, United States, 60048 | |
| Northwest Medical Specialist, PC | |
| Niles, Illinois, United States, 60714 | |
| Regional Cancer Center at Memorial Medical Center | |
| Springfield, Illinois, United States, 62781 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| Swedish Covenant Hospital | |
| Chicago, Illinois, United States, 60625 | |
| Swedish-American Regional Cancer Center | |
| Rockford, Illinois, United States, 61104-2315 | |
| Trinity Medical Center - East | |
| Moline, Illinois, United States, 61265 | |
| University of Illinois Cancer Center | |
| Chicago, Illinois, United States, 60612-7243 | |
| Veterans Affairs Medical Center - Chicago Westside Hospital | |
| Chicago, Illinois, United States, 60612 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| Saint Joseph Regional Medical Center | |
| South Bend, Indiana, United States, 46617 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309 | |
| Cedar Rapids Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316-2301 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| McFarland Clinic, P. C. | |
| Ames, Iowa, United States, 50010 | |
| St. Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | |
| Des Moines, Iowa, United States, 50309 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | |
| Des Moines, Iowa, United States, 50314 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | |
| Mason City, Iowa, United States, 50401 | |
| Mercy Capitol Hospital | |
| Des Moines, Iowa, United States, 50307 | |
| Mercy Medical Center - Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| Mercy Regional Cancer Center at Mercy Medical Center | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Siouxland Hematology-Oncology Associates | |
| Sioux City, Iowa, United States, 51101 | |
| St. Luke's Hospital | |
| Cedar Rapids, Iowa, United States, 52402 | |
| Medical Oncology and Hematology Associates - West Des Moines | |
| West Des Moines, Iowa, United States, 50266 | |
| United States, Louisiana | |
| Mary Bird Perkins Cancer Center - Baton Rouge | |
| Baton Rouge, Louisiana, United States, 70809 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Medical Center of Louisiana - New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| Pennington Cancer Center at Baton Rouge General | |
| Baton Rouge, Louisiana, United States, 70806 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Hickman Cancer Center at Bixby Medical Center | |
| Adrian, Michigan, United States, 49221 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Borgess Medical Center | |
| Kalamazooaa, Michigan, United States, 49001 | |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| Seton Cancer Institute - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Minnesota | |
| HealthEast Cancer Care at St. John's Hospital | |
| Maplewood, Minnesota, United States, 55109 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| Hennepin County Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55415 | |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Hutchinson Area Health Care | |
| Hutchinson, Minnesota, United States, 55350 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Meeker County Memorial Hospital | |
| Lichfield, Minnesota, United States, 55355 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| MeritCare Clinic - Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| Miller-Dwan Medical Center | |
| Duluth, Minnesota, United States, 55805 | |
| Park Nicollet Health Services | |
| St. Louis Park, Minnesota, United States, 55416 | |
| Regions Hospital Cancer Care Center | |
| St. Paul, Minnesota, United States, 55101 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Saint Francis Cancer Center | |
| Shakopee, Minnesota, United States, 55379 | |
| St. Joseph's Hospital | |
| St Paul, Minnesota, United States, 55102 | |
| St. Mary's - Duluth Clinic Cancer Center | |
| Duluth, Minnesota, United States, 55805 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Nebraska | |
| Bryan LGH Medical Center West | |
| Lincoln, Nebraska, United States, 68502 | |
| Cancer Resource Center - Lincoln | |
| Lincoln, Nebraska, United States, 68510 | |
| St. Elizabeth Regional Medical Center | |
| Lincoln, Nebraska, United States, 68510 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| University Medical Center of Southern Nevada | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Hamilton | |
| Hamilton, New Jersey, United States, 08690 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | |
| Flemington, New Jersey, United States, 08822 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | |
| Bronx, New York, United States, 10466 | |
| Stony Brook University Cancer Center | |
| Stony Brook, New York, United States, 11794-8174 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| MeritCare Medical Group | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 45601 | |
| Akron City Hospital | |
| Akron, Ohio, United States, 44309-2090 | |
| Aultman Hospital Cancer Center at Aultman Health Foundation | |
| Canton, Ohio, United States, 44710-1799 | |
| Blanchard Valley Medical Associates | |
| Findlay, Ohio, United States, 45840 | |
| Grant Riverside Cancer Services | |
| Columbus, Ohio, United States, 43215 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43623 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| Doctors Hospital at Ohio Health | |
| Columbus, Ohio, United States, 43228 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Firelands Regional Medical Center | |
| Sandusky, Ohio, United States, 44870 | |
| Fremont Memorial Hospital | |
| Fremont, Ohio, United States, 43420 | |
| Fulton County Health Center | |
| Wauseon, Ohio, United States, 43567 | |
| Genesis - Good Samaritan Hospital | |
| Zanesville, Ohio, United States, 43701 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| Lima Memorial Hospital | |
| Lima, Ohio, United States, 45804 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Mercy Cancer Center at Mercy Medical Center | |
| Canton, Ohio, United States, 44708 | |
| Mercy Medical Center | |
| Springfield, Ohio, United States, 45504 | |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| St. Charles Mercy Hospital | |
| Oregon, Ohio, United States, 43616 | |
| Mount Carmel West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Promedica Cancer Center at Flower Hospital | |
| Sylvania, Ohio, United States, 43560 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | |
| Westerville, Ohio, United States, 43081 | |
| St. Luke's Hospital | |
| Maumee, Ohio, United States, 43537 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| Toledo Clinic, Incorporated - Main Clinic | |
| Toledo, Ohio, United States, 43623 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Wood County Oncology Center | |
| Bowling Green, Ohio, United States, 43402 | |
| United States, Pennsylvania | |
| Geisinger Medical Group | |
| State College, Pennsylvania, United States, 16801 | |
| Chester County Hospital | |
| West Chester, Pennsylvania, United States, 19380 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Central Pennsylvania Hematology and Medical Oncology Associates, P. C. | |
| Lemoyne, Pennsylvania, United States, 17043 | |
| Guthrie Medical Center - Sayre | |
| Sayre, Pennsylvania, United States, 18840 | |
| Joan Karnell Cancer Center at Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Lewistown Hospital | |
| Lewistown, Pennsylvania, United States, 17044 | |
| Mount Nittany Medical Center | |
| State College, Pennsylvania, United States, 16803 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| PinnacleHealth Regional Cancer Center at Polyclinic Hospital | |
| Harrisburg, Pennsylvania, United States, 17105 | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| St. Luke's Hospital Cancer Center | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| York Cancer Center at Wellspan Health | |
| York, Pennsylvania, United States, 17403 | |
| United States, South Carolina | |
| Cancer Care Institute of Carolina at Aiken Regional Medical Centers | |
| Aiken, South Carolina, United States, 29801 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, West Virginia | |
| West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | |
| Charleston, West Virginia, United States, 25304 | |
| United States, Wisconsin | |
| All Saints Cancer Center at All Saints Medical Center | |
| Racine, Wisconsin, United States, 53405 | |
| Bay Area Cancer Care Center at Bay Area Medical Center | |
| Marinette, Wisconsin, United States, 54143 | |
| Dean Medical Center - Fish Hatchery | |
| Madison, Wisconsin, United States, 53715 | |
| Green Bay Oncology, Limited at St. Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | |
| La Crosse, Wisconsin, United States, 54601 | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| St. Mary's Hospital Medical Center - Green Bay | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| Study Chair: | Michael A. Carducci, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069382, ECOG-E6800 |
| Study First Received: | June 6, 2002 |
| Last Updated: | May 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00039429 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV renal cell cancer recurrent renal cell cancer |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell |
Urogenital Neoplasms Kidney Diseases Urologic Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |