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 Hospital Akron, Ohio  44304
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Aurora Presbyterian Hospital Aurora, Colorado  80012
Boulder Community Hospital Boulder, Colorado  80301-9019
Penrose Cancer Center at Penrose Hospital Colorado Springs, Colorado  80933
Porter Adventist Hospital Denver, Colorado  80210
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
Sky Ridge Medical Center Lone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
North Suburban Medical Center Thornton, Colorado  80229
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Seton Cancer Institute - Saginaw Saginaw, Michigan  48601
St. John Macomb Hospital Warren, Michigan  48093
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
CCOP - Duluth Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Mercy Cancer Center at Mercy Medical Center Canton, Ohio  44708
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Avera Cancer Institute Sioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Columbus Columbus, Ohio  43206
Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Medical Center of Central Georgia Macon, Georgia  31201
St. Vincent Mercy Medical Center Toledo, Ohio  43608
CCOP - Colorado Cancer Research Program, Incorporated Denver, Colorado  80224
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
Cancer Institute of New Jersey at Hamilton Hamilton, New Jersey  08690
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
St. Luke's Hospital Cancer Center Bethlehem, Pennsylvania  18015
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston, West Virginia  25302
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Aultman Hospital Cancer Center at Aultman Health Foundation Canton, Ohio  44710-1799
St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
Hunterdon Regional Cancer Center at Hunterdon Medical Center Flemington, New Jersey  08822
Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx, New York  10466
Lewistown Hospital Lewistown, Pennsylvania  17044
Mount Nittany Medical Center State College, Pennsylvania  16803
Chester County Hospital West Chester, Pennsylvania  19380
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Siouxland Hematology-Oncology Associates Sioux City, Iowa  51101
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grant Riverside Cancer Services Columbus, Ohio  43215
Mount Carmel West Hospital Columbus, Ohio  43222
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital Westerville, Ohio  43081
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
University of Illinois Cancer Center Chicago, Illinois  60612-7243
Swedish-American Regional Cancer Center Rockford, Illinois  61104-2315
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
MBCCOP-Medical College of Georgia Cancer Center Augusta, Georgia  30912-4000
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Elkhart General Hospital Elkhart, Indiana  46515
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Lakeland, Florida  33805
Veterans Affairs Medical Center - Chicago Westside Hospital Chicago, Illinois  60612
Hematology Oncology Associates - Skokie Skokie, Illinois  60076
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Joan Karnell Cancer Center at Pennsylvania Hospital Philadelphia, Pennsylvania  19107
St. Mary-Corwin Regional Medical Center Pueblo, Colorado  81004
Swedish Covenant Hospital Chicago, Illinois  60625
Mercy Hospital and Medical Center Chicago, Illinois  60616
Hematology and Oncology Associates Chicago, Illinois  60611
Midwest Center for Hematology/Oncology Joliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville, Illinois  60048
Trinity Medical Center - East Moline, Illinois  61265
Northwest Medical Specialist, PC Niles, Illinois  60714
Midwest Cancer Research Group, Incorporated Skokie, Illinois  60077
Hematology/Oncology of the North Shore at Gross Point Medical Center Skokie, Illinois  60076
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
McFarland Clinic, P. C. Ames, Iowa  50010
St. Luke's Hospital Cedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Pennington Cancer Center at Baton Rouge General Baton Rouge, Louisiana  70806
Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge, Louisiana  70809
Medical Center of Louisiana - New Orleans New Orleans, Louisiana  70112
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital Ann Arbor, Michigan  48106-0995
MeritCare Clinic - Bemidji Bemidji, Minnesota  56601
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Bryan LGH Medical Center West Lincoln, Nebraska  68502
St. Elizabeth Regional Medical Center Lincoln, Nebraska  68510
MeritCare Medical Group Fargo, North Dakota  58122
Wood County Oncology Center Bowling Green, Ohio  43402
Blanchard Valley Medical Associates Findlay, Ohio  45840
Fremont Memorial Hospital Fremont, Ohio  43420
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
St. Charles Mercy Hospital Oregon, Ohio  43616
Firelands Regional Medical Center Sandusky, Ohio  44870
Mercy Medical Center Springfield, Ohio  45504
Promedica Cancer Center at Flower Hospital Sylvania, Ohio  43560
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
Fulton County Health Center Wauseon, Ohio  43567
Green Bay Oncology, Limited at St. Vincent Hospital Green Bay, Wisconsin  54301-3526
Dean Medical Center - Fish Hatchery Madison, Wisconsin  53715
Miller-Dwan Medical Center Duluth, Minnesota  55805
Geisinger Medical Group State College, Pennsylvania  16801
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Saint Francis Cancer Center Shakopee, Minnesota  55379
St. Joseph's Hospital St Paul, Minnesota  55102
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Guthrie Medical Center - Sayre Sayre, Pennsylvania  18840
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
York Cancer Center at Wellspan Health York, Pennsylvania  17403
PinnacleHealth Regional Cancer Center at Polyclinic Hospital Harrisburg, Pennsylvania  17105
Cancer Care Institute of Carolina at Aiken Regional Medical Centers Aiken, South Carolina  29801
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center Boca Raton, Florida  33486
Veterans Affairs Medical Center - Augusta Augusta, Georgia  30904
Elmhurst Memorial Hospital Elmhurst, Illinois  60126
Northeast Georgia Cancer Care, LLC Athens, Georgia  30607
Central Pennsylvania Hematology and Medical Oncology Associates, P. C. Lemoyne, Pennsylvania  17043
All Saints Cancer Center at All Saints Medical Center Racine, Wisconsin  53405