Kidney Cancer Clinical Trial

Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

Summary

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.

View Full Description

Full Description

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).

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed locally recurrent or metastatic renal cell carcinoma that is not amenable to resection

Progressive disease, defined by 1 of the following:

The appearance of 1 or more new lesions
At least a 20% increase in the sum of the longest diameters of the target lesions (taking as a reference the smallest sum of the longest diameters recorded since the baseline measurements) (measurable disease stratum closed to accrual as of 7/16/04.)

One of the following disease characteristics:

Disease manifested solely by bone metastases

At least 1 measurable lesion (measurable disease stratum closed to accrual as of 7/16/04.)

At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
No prior or concurrent brain metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC at least 2,000/mm^3 OR
Absolute neutrophil count greater than 1,000/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 9 g/dL

Hepatic:

Bilirubin less than 1.5 mg/dL
AST and/or ALT less than 1.5 times upper limit of normal (ULN)

Renal:

Creatinine less than 1.5 times ULN

Cardiovascular:

No history of New York Heart Association class II-IV heart disease

Pulmonary:

No significant pulmonary disease requiring pulse steroid therapy within the past 3 months

Other:

No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No other serious concurrent medical illness that would preclude study participation
No active infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 4 weeks since prior biologic therapy/immunotherapy and recovered

No more than 1 prior regimen* of biologic therapy/immunotherapy (e.g., interleukin-2, interferon, thalidomide, or combination)

Prior sargramostim (GM-CSF) is not counted as prior biological therapy NOTE: *A regimen is considered to be at least 4 weeks of treatment

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

At least 4 weeks since prior hormonal agents (e.g., megestrol or tamoxifen) and recovered

Radiotherapy:

At least 4 weeks since prior radiotherapy and recovered
Prior radiotherapy for local control or palliation of painful bony lesion allowed
No prior radiotherapy to target lesions
No concurrent radiotherapy for palliation or any other indication

Surgery:

At least 4 weeks since prior surgery and recovered
Prior nephrectomy allowed

Other:

Prior bisphosphonates allowed

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT00039429

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 153 Locations for this study

See Locations Near You

Mayo Clinic Scottsdale
Scottsdale Arizona, 85259, United States
Aurora Presbyterian Hospital
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs Colorado, 80933, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver Colorado, 80218, United States
St. Joseph Hospital
Denver Colorado, 80218, United States
Rose Medical Center
Denver Colorado, 80220, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver Colorado, 80224, United States
Swedish Medical Center
Englewood Colorado, 80110, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont Colorado, 80502, United States
St. Mary-Corwin Regional Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
Boca Raton Florida, 33486, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland Florida, 33805, United States
Northeast Georgia Cancer Care, LLC
Athens Georgia, 30607, United States
Veterans Affairs Medical Center - Augusta
Augusta Georgia, 30904, United States
MBCCOP-Medical College of Georgia Cancer Center
Augusta Georgia, 30912, United States
Medical Center of Central Georgia
Macon Georgia, 31208, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
Hematology and Oncology Associates
Chicago Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
University of Illinois Cancer Center
Chicago Illinois, 60612, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago Illinois, 60612, United States
Mercy Hospital and Medical Center
Chicago Illinois, 60616, United States
Swedish Covenant Hospital
Chicago Illinois, 60625, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Elmhurst Memorial Hospital
Elmhurst Illinois, 60126, United States
Hinsdale Hematology Oncology Associates
Hinsdale Illinois, 60521, United States
Midwest Center for Hematology/Oncology
Joliet Illinois, 60432, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville Illinois, 60048, United States
Trinity Medical Center - East
Moline Illinois, 61265, United States
Northwest Medical Specialist, PC
Niles Illinois, 60714, United States
Swedish-American Regional Cancer Center
Rockford Illinois, 61104, United States
Hematology Oncology Associates - Skokie
Skokie Illinois, 60076, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie Illinois, 60076, United States
Midwest Cancer Research Group, Incorporated
Skokie Illinois, 60077, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend Indiana, 46617, United States
McFarland Clinic, P. C.
Ames Iowa, 50010, United States
St. Luke's Hospital
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Oncology Associates
Cedar Rapids Iowa, 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City Iowa, 50401, United States
Siouxland Hematology-Oncology Associates
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines Iowa, 50266, United States
Pennington Cancer Center at Baton Rouge General
Baton Rouge Louisiana, 70806, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge Louisiana, 70809, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Medical Center of Louisiana - New Orleans
New Orleans Louisiana, 70112, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Hickman Cancer Center at Bixby Medical Center
Adrian Michigan, 49221, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Seton Cancer Institute - Saginaw
Saginaw Michigan, 48601, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph Michigan, 49085, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
MeritCare Clinic - Bemidji
Bemidji Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller-Dwan Medical Center
Duluth Minnesota, 55805, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth Minnesota, 55805, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield Minnesota, 55355, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Health Services
Saint Louis Park Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul Minnesota, 55101, United States
St. Joseph's Hospital
Saint Paul Minnesota, 55102, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Saint Francis Cancer Center
Shakopee Minnesota, 55379, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Bryan LGH Medical Center West
Lincoln Nebraska, 68502, United States
Cancer Resource Center - Lincoln
Lincoln Nebraska, 68510, United States
St. Elizabeth Regional Medical Center
Lincoln Nebraska, 68510, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington New Jersey, 08822, United States
Cancer Institute of New Jersey at Hamilton
Hamilton New Jersey, 08690, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick New Jersey, 08903, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx New York, 10461, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx New York, 10466, United States
Stony Brook University Cancer Center
Stony Brook New York, 11794, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
MeritCare Medical Group
Fargo North Dakota, 58122, United States
Akron City Hospital
Akron Ohio, 44309, United States
Wood County Oncology Center
Bowling Green Ohio, 43402, United States
Mercy Cancer Center at Mercy Medical Center
Canton Ohio, 44708, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton Ohio, 44710, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
CCOP - Columbus
Columbus Ohio, 43215, United States
Grant Riverside Cancer Services
Columbus Ohio, 43215, United States
Mount Carmel West Hospital
Columbus Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus Ohio, 43228, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Blanchard Valley Medical Associates
Findlay Ohio, 45840, United States
Fremont Memorial Hospital
Fremont Ohio, 43420, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
Lima Memorial Hospital
Lima Ohio, 45804, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta Ohio, 45750, United States
St. Luke's Hospital
Maumee Ohio, 43537, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark Ohio, 43055, United States
St. Charles Mercy Hospital
Oregon Ohio, 43616, United States
Firelands Regional Medical Center
Sandusky Ohio, 44870, United States
Mercy Medical Center
Springfield Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield Ohio, 45505, United States
Promedica Cancer Center at Flower Hospital
Sylvania Ohio, 43560, United States
Toledo Hospital
Toledo Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo Ohio, 43623, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo Ohio, 43623, United States
Fulton County Health Center
Wauseon Ohio, 43567, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville Ohio, 43081, United States
Genesis - Good Samaritan Hospital
Zanesville Ohio, 43701, United States
St. Luke's Hospital Cancer Center
Bethlehem Pennsylvania, 18015, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg Pennsylvania, 17105, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Central Pennsylvania Hematology and Medical Oncology Associates, P. C.
Lemoyne Pennsylvania, 17043, United States
Lewistown Hospital
Lewistown Pennsylvania, 17044, United States
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia Pennsylvania, 19107, United States
Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Guthrie Medical Center - Sayre
Sayre Pennsylvania, 18840, United States
Geisinger Medical Group
State College Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College Pennsylvania, 16803, United States
Chester County Hospital
West Chester Pennsylvania, 19380, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
York Cancer Center at Wellspan Health
York Pennsylvania, 17403, United States
Cancer Care Institute of Carolina at Aiken Regional Medical Centers
Aiken South Carolina, 29801, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57117, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston West Virginia, 25304, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States
Dean Medical Center - Fish Hatchery
Madison Wisconsin, 53715, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette Wisconsin, 54143, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States
All Saints Cancer Center at All Saints Medical Center
Racine Wisconsin, 53405, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT00039429

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.