Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

NCT00039429 | Completed Phase 2

• 2 other identifiers: CDR0000069382E6800
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 177

Brief 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.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer; recurrent renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival at 6 months

• Toxicity

Interventions

atrasentan hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (177)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Aurora Presbyterian Hospital

Aurora, Colorado, 80012, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301-9019, United States

Location

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, 80933, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

St. Joseph Hospital

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

CCOP - Colorado Cancer Research Program, Incorporated

Denver, Colorado, 80224-2522, United States

Location

Swedish Medical Center

Englewood, Colorado, 80110, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, 80502, United States

Location

St. Mary-Corwin Regional Medical Center

Pueblo, Colorado, 81004, United States

Location

North Suburban Medical Center

Thornton, Colorado, 80229, United States

Location

Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center

Boca Raton, Florida, 33486, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

Northeast Georgia Cancer Care, LLC

Athens, Georgia, 30607, United States

Location

Veterans Affairs Medical Center - Augusta

Augusta, Georgia, 30904, United States

Location

MBCCOP-Medical College of Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31208, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Hematology and Oncology Associates

Chicago, Illinois, 60611, United States

Location

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, 60611, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

Veterans Affairs Medical Center - Chicago Westside Hospital

Chicago, Illinois, 60612, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616, United States

Location

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Elmhurst Memorial Hospital

Elmhurst, Illinois, 60126, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

Midwest Center for Hematology/Oncology

Joliet, Illinois, 60432, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

North Shore Oncology and Hematology Associates, Limited - Libertyville

Libertyville, Illinois, 60048, United States

Location

Trinity Medical Center - East

Moline, Illinois, 61265, United States

Location

Northwest Medical Specialist, PC

Niles, Illinois, 60714, United States

Location

Swedish-American Regional Cancer Center

Rockford, Illinois, 61104-2315, United States

Location

Hematology Oncology Associates - Skokie

Skokie, Illinois, 60076, United States

Location

Hematology/Oncology of the North Shore at Gross Point Medical Center

Skokie, Illinois, 60076, United States

Location

Midwest Cancer Research Group, Incorporated

Skokie, Illinois, 60077, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Saint Joseph Regional Medical Center

South Bend, Indiana, 46617, United States

Location

McFarland Clinic, P. C.

Ames, Iowa, 50010, United States

Location

St. Luke's Hospital

Cedar Rapids, Iowa, 52402, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Capitol Hospital

Des Moines, Iowa, 50307, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, 50314, United States

Location

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, 50316-2301, United States

Location

Mercy Cancer Center at Mercy Medical Center - North Iowa

Mason City, Iowa, 50401, United States

Location

Siouxland Hematology-Oncology Associates

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Medical Oncology and Hematology Associates - West Des Moines

West Des Moines, Iowa, 50266, United States

Location

Pennington Cancer Center at Baton Rouge General

Baton Rouge, Louisiana, 70806, United States

Location

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Medical Center of Louisiana - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Seton Cancer Institute - Saginaw

Saginaw, Michigan, 48601, United States

Location

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

MeritCare Clinic - Bemidji

Bemidji, Minnesota, 56601, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Miller-Dwan Medical Center

Duluth, Minnesota, 55805, United States

Location

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

Meeker County Memorial Hospital

Litchfield, Minnesota, 55355, United States

Location

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Health Services

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Saint Francis Cancer Center

Shakopee, Minnesota, 55379, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Bryan LGH Medical Center West

Lincoln, Nebraska, 68502, United States

Location

Cancer Resource Center - Lincoln

Lincoln, Nebraska, 68510, United States

Location

St. Elizabeth Regional Medical Center

Lincoln, Nebraska, 68510, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Hunterdon Regional Cancer Center at Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

Location

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-8174, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Our Lady of Mercy Medical Center Comprehensive Cancer Center

The Bronx, New York, 10466, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

MeritCare Medical Group

Fargo, North Dakota, 58122, United States

Location

Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Wood County Oncology Center

Bowling Green, Ohio, 43402, United States

Location

Mercy Cancer Center at Mercy Medical Center

Canton, Ohio, 44708, United States

Location

Aultman Hospital Cancer Center at Aultman Health Foundation

Canton, Ohio, 44710-1799, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

MetroHealth's Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Riverside Cancer Services

Columbus, Ohio, 43215, United States

Location

Mount Carmel West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Fremont Memorial Hospital

Fremont, Ohio, 43420, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

St. Luke's Hospital

Maumee, Ohio, 43537, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

Mercy Medical Center

Springfield, Ohio, 45504, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

Promedica Cancer Center at Flower Hospital

Sylvania, Ohio, 43560, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623, United States

Location

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, 43623, United States

Location

Fulton County Health Center

Wauseon, Ohio, 43567, United States

Location

Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

Westerville, Ohio, 43081, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-0001, United States

Location

PinnacleHealth Regional Cancer Center at Polyclinic Hospital

Harrisburg, Pennsylvania, 17105, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Central Pennsylvania Hematology and Medical Oncology Associates, P. C.

Lemoyne, Pennsylvania, 17043, United States

Location

Lewistown Hospital

Lewistown, Pennsylvania, 17044, United States

Location

Joan Karnell Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Guthrie Medical Center - Sayre

Sayre, Pennsylvania, 18840, United States

Location

Geisinger Medical Group

State College, Pennsylvania, 16801, United States

Location

Mount Nittany Medical Center

State College, Pennsylvania, 16803, United States

Location

Chester County Hospital

West Chester, Pennsylvania, 19380, United States

Location

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

York Cancer Center at Wellspan Health

York, Pennsylvania, 17403, United States

Location

Cancer Care Institute of Carolina at Aiken Regional Medical Centers

Aiken, South Carolina, 29801, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

Charleston, West Virginia, 25304, United States

Location

Green Bay Oncology, Limited at St. Vincent Hospital

Green Bay, Wisconsin, 54301-3526, United States

Location

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, 54303, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Dean Medical Center - Fish Hatchery

Madison, Wisconsin, 53715, United States

Location

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

All Saints Cancer Center at All Saints Medical Center

Racine, Wisconsin, 53405, United States

Location

Related Publications (1)

• Manola J, Carducci M, Nair S, et al.: Phase II ECOG trial of atrasentan in advanced renal cell carcinoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-5102, 260s, 2007.

  RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Atrasentan

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Benzodioxoles; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrrolidines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michael A. Carducci, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: July 14, 2003
• Primary Completion: April 1, 2006
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (177)