Know Cancer

or
forgot password

A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

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).

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 6 months

Safety Issue:

No

Principal Investigator

Michael A. Carducci, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000069382

NCT ID:

NCT00039429

Start Date:

May 2003

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
North Suburban Medical CenterThornton, Colorado  80229
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
CCOP - MeritCare HospitalFargo, North Dakota  58122
Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - ColumbusColumbus, Ohio  43206
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Medical Center of Central GeorgiaMacon, Georgia  31201
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Hunterdon Regional Cancer Center at Hunterdon Medical CenterFlemington, New Jersey  08822
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
Chester County HospitalWest Chester, Pennsylvania  19380
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Mount Carmel West HospitalColumbus, Ohio  43222
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Elkhart General HospitalElkhart, Indiana  46515
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois  60612
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Joan Karnell Cancer Center at Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
Swedish Covenant HospitalChicago, Illinois  60625
Mercy Hospital and Medical CenterChicago, Illinois  60616
Hematology and Oncology AssociatesChicago, Illinois  60611
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
Trinity Medical Center - EastMoline, Illinois  61265
Northwest Medical Specialist, PCNiles, Illinois  60714
Midwest Cancer Research Group, IncorporatedSkokie, Illinois  60077
Hematology/Oncology of the North Shore at Gross Point Medical CenterSkokie, Illinois  60076
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
McFarland Clinic, P. C.Ames, Iowa  50010
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Pennington Cancer Center at Baton Rouge GeneralBaton Rouge, Louisiana  70806
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Bryan LGH Medical Center WestLincoln, Nebraska  68502
St. Elizabeth Regional Medical CenterLincoln, Nebraska  68510
MeritCare Medical GroupFargo, North Dakota  58122
Wood County Oncology CenterBowling Green, Ohio  43402
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Fremont Memorial HospitalFremont, Ohio  43420
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
St. Charles Mercy HospitalOregon, Ohio  43616
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Medical CenterSpringfield, Ohio  45504
Promedica Cancer Center at Flower HospitalSylvania, Ohio  43560
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Dean Medical Center - Fish HatcheryMadison, Wisconsin  53715
Miller-Dwan Medical CenterDuluth, Minnesota  55805
Geisinger Medical GroupState College, Pennsylvania  16801
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Saint Francis Cancer CenterShakopee, Minnesota  55379
St. Joseph's HospitalSt Paul, Minnesota  55102
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Guthrie Medical Center - SayreSayre, Pennsylvania  18840
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
York Cancer Center at Wellspan HealthYork, Pennsylvania  17403
PinnacleHealth Regional Cancer Center at Polyclinic HospitalHarrisburg, Pennsylvania  17105
Cancer Care Institute of Carolina at Aiken Regional Medical CentersAiken, South Carolina  29801
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main CenterBoca Raton, Florida  33486
Veterans Affairs Medical Center - AugustaAugusta, Georgia  30904
Elmhurst Memorial HospitalElmhurst, Illinois  60126
Northeast Georgia Cancer Care, LLCAthens, Georgia  30607
Central Pennsylvania Hematology and Medical Oncology Associates, P. C.Lemoyne, Pennsylvania  17043
All Saints Cancer Center at All Saints Medical CenterRacine, Wisconsin  53405