Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00039429

Collaborator

National Cancer Institute (NCI) (NIH)

180

Enrollment

177

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Drug: atrasentan hydrochloride	Phase 2

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Progression-free survival at 6 months []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259
2	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
3	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
4	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
5	Porter Adventist Hospital	Denver	Colorado	United States	80210
6	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
7	St. Joseph Hospital	Denver	Colorado	United States	80218
8	Rose Medical Center	Denver	Colorado	United States	80220
9	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado	United States	80224-2522
10	Swedish Medical Center	Englewood	Colorado	United States	80110
11	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
12	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80502
13	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
14	North Suburban Medical Center	Thorton	Colorado	United States	80229
15	Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center	Boca Raton	Florida	United States	33486
16	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
17	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida	United States	33805
18	Northeast Georgia Cancer Care, LLC	Athens	Georgia	United States	30607
19	Veterans Affairs Medical Center - Augusta	Augusta	Georgia	United States	30904
20	MBCCOP-Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912
21	Medical Center of Central Georgia	Macon	Georgia	United States	31208
22	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
23	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
24	Hematology and Oncology Associates	Chicago	Illinois	United States	60611
25	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611
26	University of Illinois Cancer Center	Chicago	Illinois	United States	60612-7243
27	Veterans Affairs Medical Center - Chicago Westside Hospital	Chicago	Illinois	United States	60612
28	Mercy Hospital and Medical Center	Chicago	Illinois	United States	60616
29	Swedish Covenant Hospital	Chicago	Illinois	United States	60625
30	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
31	Elmhurst Memorial Hospital	Elmhurst	Illinois	United States	60126
32	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
33	Midwest Center for Hematology/Oncology	Joliet	Illinois	United States	60432
34	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
35	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois	United States	60048
36	Trinity Medical Center - East	Moline	Illinois	United States	61265
37	Northwest Medical Specialist, PC	Niles	Illinois	United States	60714
38	Swedish-American Regional Cancer Center	Rockford	Illinois	United States	61104-2315
39	Hematology Oncology Associates - Skokie	Skokie	Illinois	United States	60076
40	Hematology/Oncology of the North Shore at Gross Point Medical Center	Skokie	Illinois	United States	60076
41	Midwest Cancer Research Group, Incorporated	Skokie	Illinois	United States	60077
42	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781
43	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
44	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
45	Elkhart General Hospital	Elkhart	Indiana	United States	46515
46	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
47	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
48	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
49	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
50	Saint Joseph Regional Medical Center	South Bend	Indiana	United States	46617
51	McFarland Clinic, P. C.	Ames	Iowa	United States	50010
52	St. Luke's Hospital	Cedar Rapids	Iowa	United States	52402
53	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
54	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
55	Mercy Capitol Hospital	Des Moines	Iowa	United States	50307
56	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
57	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
58	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
59	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
60	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
61	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316-2301
62	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
63	Siouxland Hematology-Oncology Associates	Sioux City	Iowa	United States	51101
64	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
65	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
66	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa	United States	50266
67	Pennington Cancer Center at Baton Rouge General	Baton Rouge	Louisiana	United States	70806
68	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
69	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
70	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
71	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
72	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
73	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
74	St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106-0995
75	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
76	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
77	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
78	Borgess Medical Center	Kalamazooaa	Michigan	United States	49001
79	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
80	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
81	Seton Cancer Institute - Saginaw	Saginaw	Michigan	United States	48601
82	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	St. Joseph	Michigan	United States	49085
83	St. John Macomb Hospital	Warren	Michigan	United States	48093
84	MeritCare Clinic - Bemidji	Bemidji	Minnesota	United States	56601
85	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
86	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
87	CCOP - Duluth	Duluth	Minnesota	United States	55805
88	Miller-Dwan Medical Center	Duluth	Minnesota	United States	55805
89	St. Mary's - Duluth Clinic Cancer Center	Duluth	Minnesota	United States	55805
90	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
91	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota	United States	55432
92	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
93	Meeker County Memorial Hospital	Lichfield	Minnesota	United States	55355
94	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
95	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
96	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
97	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota	United States	55422-2900
98	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
99	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
100	Saint Francis Cancer Center	Shakopee	Minnesota	United States	55379
101	St. Joseph's Hospital	St Paul	Minnesota	United States	55102
102	Park Nicollet Health Services	St. Louis Park	Minnesota	United States	55416
103	Regions Hospital Cancer Care Center	St. Paul	Minnesota	United States	55101
104	United Hospital	St. Paul	Minnesota	United States	55102
105	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
106	Bryan LGH Medical Center West	Lincoln	Nebraska	United States	68502
107	Cancer Resource Center - Lincoln	Lincoln	Nebraska	United States	68510
108	St. Elizabeth Regional Medical Center	Lincoln	Nebraska	United States	68510
109	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
110	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
111	Hunterdon Regional Cancer Center at Hunterdon Medical Center	Flemington	New Jersey	United States	08822
112	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey	United States	08690
113	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
114	Albert Einstein Cancer Center at Albert Einstein College of Medicine	Bronx	New York	United States	10461
115	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York	United States	10466
116	Stony Brook University Cancer Center	Stony Brook	New York	United States	11794-8174
117	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
118	MeritCare Medical Group	Fargo	North Dakota	United States	58122
119	Akron City Hospital	Akron	Ohio	United States	44309-2090
120	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
121	Mercy Cancer Center at Mercy Medical Center	Canton	Ohio	United States	44708
122	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio	United States	44710-1799
123	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
124	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio	United States	44109
125	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
126	CCOP - Columbus	Columbus	Ohio	United States	43215
127	Grant Riverside Cancer Services	Columbus	Ohio	United States	43215
128	Mount Carmel West Hospital	Columbus	Ohio	United States	43222
129	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
130	Grady Memorial Hospital	Delaware	Ohio	United States	43015
131	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
132	Fremont Memorial Hospital	Fremont	Ohio	United States	43420
133	Fairfield Medical Center	Lancaster	Ohio	United States	43130
134	Lima Memorial Hospital	Lima	Ohio	United States	45804
135	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
136	St. Luke's Hospital	Maumee	Ohio	United States	43537
137	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
138	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
139	Firelands Regional Medical Center	Sandusky	Ohio	United States	44870
140	Mercy Medical Center	Springfield	Ohio	United States	45504
141	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
142	Promedica Cancer Center at Flower Hospital	Sylvania	Ohio	United States	43560
143	Toledo Hospital	Toledo	Ohio	United States	43606
144	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
145	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
146	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43623
147	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
148	Fulton County Health Center	Wauseon	Ohio	United States	43567
149	Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital	Westerville	Ohio	United States	43081
150	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
151	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania	United States	18015
152	Geisinger Medical Center	Danville	Pennsylvania	United States	17822-0001
153	PinnacleHealth Regional Cancer Center at Polyclinic Hospital	Harrisburg	Pennsylvania	United States	17105
154	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
155	Central Pennsylvania Hematology and Medical Oncology Associates, P. C.	Lemoyne	Pennsylvania	United States	17043
156	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
157	Joan Karnell Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
158	Reading Hospital and Medical Center	Reading	Pennsylvania	United States	19612-6052
159	Guthrie Medical Center - Sayre	Sayre	Pennsylvania	United States	18840
160	Geisinger Medical Group	State College	Pennsylvania	United States	16801
161	Mount Nittany Medical Center	State College	Pennsylvania	United States	16803
162	Chester County Hospital	West Chester	Pennsylvania	United States	19380
163	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
164	York Cancer Center at Wellspan Health	York	Pennsylvania	United States	17403
165	Cancer Care Institute of Carolina at Aiken Regional Medical Centers	Aiken	South Carolina	United States	29801
166	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
167	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota	United States	57117-5039
168	West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division	Charleston	West Virginia	United States	25304
169	Green Bay Oncology, Limited at St. Vincent Hospital	Green Bay	Wisconsin	United States	54301-3526
170	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
171	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
172	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
173	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
174	Dean Medical Center - Fish Hatchery	Madison	Wisconsin	United States	53715
175	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
176	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
177	All Saints Cancer Center at All Saints Medical Center	Racine	Wisconsin	United States	53405