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Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
This study has been completed.
First Received: June 6, 2002   Last Updated: May 29, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: May 2003
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039429

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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
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Michael A. Carducci, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
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.

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

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 30, 2009