Combination Chemotherapy in Treating Patients With Bladder Cancer

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00014534
Collaborator
National Cancer Institute (NCI) (NIH)
42
285
2
61
0.1
0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients who have advanced bladder cancer.

Condition or Disease Intervention/Treatment Phase
  • Biological: filgrastim
  • Drug: cisplatin
  • Drug: doxorubicin hydrochloride
  • Drug: gemcitabine hydrochloride
Phase 3

Detailed Description

OBJECTIVES:

Primary

  • Compare the survival of patients with completely resected locally advanced transitional cell carcinoma of the bladder treated with adjuvant doxorubicin and gemcitabine followed by paclitaxel and cisplatin vs adjuvant cisplatin and gemcitabine.

Secondary

  • Compare the toxicity profiles of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to primary tumor status (<T4 vs T4), number of positive lymph nodes (0 or unknown vs 1-5 vs >5), and number of dissected nodes (0-10 or unknown vs > 10). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive adjuvant gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

  • Arm II: Patients receive adjuvant doxorubicin IV over 45 minutes followed by gemcitabine IV over 2 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily on days 3-10. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 14 days after the completion of doxorubicin and gemcitabine, patients receive paclitaxel IV over 3 hours and cisplatin IV over 20-30 minutes on day 1. Patients also receive G-CSF SC daily on days 3-10 or 4-11. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 18 months, every 6 months for 18 months, and then annually thereafter.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Study Comparing Sequential Chemotherapy (AG-ITP) To Cisplatin And Gemcitabine As Adjuvant Treatment After Cystectomy For Transitional Cell Carcinoma Of The Bladder
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Jul 1, 2005
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Gemcitabine + cisplatin

Drug: cisplatin
60 mg/sq m IV

Drug: gemcitabine hydrochloride
1000 mg/ sq m IV for Gem + cis arm and 2000 mg/sq m IV for gem + dox + peg arm

Active Comparator: Gemcitabine + Doxorubicin + Pegfilgrastim

Biological: filgrastim
6 mg sub Q

Drug: doxorubicin hydrochloride
50 mg/ sq m IV

Drug: gemcitabine hydrochloride
1000 mg/ sq m IV for Gem + cis arm and 2000 mg/sq m IV for gem + dox + peg arm

Outcome Measures

Primary Outcome Measures

  1. Overall survival [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Histologically confirmed transitional cell carcinoma of the bladder

  • Any T, N+, M0 OR

  • T3a-4a, N0, M0

  • At least 6 weeks but no more than 3 months since prior complete resection of bladder

  • Cystoprostatectomy plus pelvic lymph node dissection in males

  • Cystectomy/total abdominal hysterectomy/bilateral salpingo-oophorectomy plus pelvic lymph node dissection in females

  • Negative surgical margins

  • Carcinoma in situ allowed

  • No partial cystectomy or transurethral bladder tumor resection as definitive loco-regional therapy

  • Prostate cancer detected in resected specimen allowed if post-operative PSA is no more than 0.05 mg/dL

  • No metastatic or recurrent disease by post-operative chest x-ray and CT scan of abdomen and pelvis

PATIENT CHARACTERISTICS:
Age:
  • 18 and over
Performance status:
  • ECOG 0-1
Hematopoietic:
  • Absolute neutrophil count ≥ 1,500/mm^3

  • Platelet count ≥ 150,000/mm^3

Hepatic:
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)

  • Alkaline phosphatase ≤ 2 times ULN

  • AST ≤ 2 times ULN

Renal:
  • Creatinine ≤ 1.5 mg/dL OR

  • Creatinine clearance ≥ 60 mL/min

Cardiovascular:
  • Normal cardiac function by history, physical exam, or chest radiograph

  • Left ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram, for prior cardiac disease

  • No New York Heart Association class III or IV heart disease

  • No serious cardiac arrhythmias including first-, second-, and third-degree heart block

Other:
  • Negative pregnancy test

  • No uncontrolled infection

  • No other active cancer within the past 5 years except non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:
Biologic therapy:
  • Not specified
Chemotherapy:
  • No prior systemic chemotherapy
Endocrine therapy:
  • Not specified
Radiotherapy:
  • No prior radiotherapy to bladder

Contacts and Locations

Locations

Site City State Country Postal Code
1 CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale Arizona United States 85259
2 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
3 Arroyo Grande Community Hospital Arroyo Grande California United States 93420
4 Rebecca and John Moores UCSD Cancer Center San Diego California United States 92103
5 Kaiser Permanente Medical Office -Vandever Medical Office San Diego California United States 92120
6 Veterans Affairs Medical Center - San Diego San Diego California United States 92161
7 UCSF Comprehensive Cancer Center San Francisco California United States 94115
8 Veterans Affairs Medical Center - San Francisco San Francisco California United States 94121
9 Aurora Presbyterian Hospital Aurora Colorado United States 80012
10 Boulder Community Hospital Boulder Colorado United States 80301
11 Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado United States 80933
12 Porter Adventist Hospital Denver Colorado United States 80210
13 Presbyterian - St. Luke's Medical Center Denver Colorado United States 80218
14 St. Joseph Hospital Denver Colorado United States 80218
15 Rose Medical Center Denver Colorado United States 80220
16 CCOP - Colorado Cancer Research Program, Incorporated Denver Colorado United States 80224-2522
17 Swedish Medical Center Englewood Colorado United States 80110
18 Front Range Cancer Specialists Fort Collins Colorado United States 80524
19 Poudre Valley Hospital Fort Collins Colorado United States 80524
20 Sky Ridge Medical Center Lone Tree Colorado United States 80124
21 Hope Cancer Care Center at Longmont United Hospital Longmont Colorado United States 80502
22 St. Mary-Corwin Regional Medical Center Pueblo Colorado United States 81004
23 North Suburban Medical Center Thorton Colorado United States 80229
24 Beebe Medical Center Lewes Delaware United States 19958
25 CCOP - Christiana Care Health Services Newark Delaware United States 19718
26 St. Francis Hospital Wilmington Delaware United States 19805
27 Lombardi Cancer Center at Georgetown University Medical Center Washington District of Columbia United States 20007
28 Walter Reed Army Medical Center Washington District of Columbia United States 20307
29 Lynn Regional Cancer Center of Boca Raton Community Hospital Boca Raton Florida United States 33486
30 Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale Florida United States 33308
31 Memorial Cancer Institute at Memorial Regional Hospital Hollywood Florida United States 33021
32 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224-9980
33 Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter Florida United States 33458
34 Watson Clinic Lakeland Florida United States 33805
35 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
36 Phoebe Cancer Center at Phoebe Putney Memorial Hospital Albany Georgia United States 31703
37 Emory University Hospital - Atlanta Altanta Georgia United States 30322
38 Hematology and Oncology of Northeast Georgia Athens Georgia United States 30607
39 MBCCOP-Medical College of Georgia Cancer Center Augusta Georgia United States 30912
40 John B. Amos Community Cancer Center Columbus Georgia United States 31902
41 Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia United States 31403
42 Rush-Copley Cancer Care Center Aurora Illinois United States 60507
43 St. Joseph Medical Center Bloomington Illinois United States 61701
44 Graham Hospital Canton Illinois United States 61520
45 Memorial Hospital Carthage Illinois United States 62321
46 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
47 Louis A. Weiss Memorial Hospital Chicago Illinois United States 60640
48 Eureka Hospital Eureka Illinois United States 61530
49 Galesburg Clinic Galesburg Illinois United States 61401
50 Galesburg Cottage Hospital Galesburg Illinois United States 61401
51 InterCommunity Cancer Center of Western Illinois Galesburg Illinois United States 61401
52 Mason District Hospital Havana Illinois United States 62644
53 Hopedale Medical Complex Hopedale Illinois United States 61747
54 Joliet Oncology Hematology Associates, Limited - West Joliet Illinois United States 60435
55 Provena St. Mary's Wasser Regional Cancer Center - Kankakee Kankakee Illinois United States 60901
56 Kewanee Hospital Kewanee Illinois United States 61443
57 McDonough District Hospital Macomb Illinois United States 61455
58 Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois United States 60153
59 BroMenn Regional Medical Center Normal Illinois United States 61761
60 Community Cancer Center Normal Illinois United States 61761
61 Community Hospital of Ottawa Ottawa Illinois United States 61350
62 Oncology Hematology Associates of Central Illinois - Ottawa Ottawa Illinois United States 61350
63 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
64 Methodist Medical Center of Illinois Peoria Illinois United States 61603
65 Proctor Hospital Peoria Illinois United States 61614
66 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
67 Oncology/Hematology Associates of Central Illinois, P.C. Peoria Illinois United States 61615
68 OSF St. Francis Medical Center Peoria Illinois United States 61637
69 Illinois Valley Community Hospital Peru Illinois United States 61354
70 Perry Memorial Hospital Princeton Illinois United States 61356
71 St. Margaret's Hospital Spring Valley Illinois United States 61362
72 Valley Cancer Center Spring Valley Illinois United States 61362
73 Regional Cancer Center at Memorial Medical Center Springfield Illinois United States 62781-0001
74 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
75 CCOP - Carle Cancer Center Urbana Illinois United States 61801
76 St. Francis Hospital and Health Centers Beech Grove Indiana United States 46107
77 Elkhart General Hospital Elkhart Indiana United States 46515
78 Indiana University Cancer Center Indianapolis Indiana United States 46202
79 William N. Wishard Memorial Hospital Indianapolis Indiana United States 46202
80 Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana United States 46350
81 Saint Anthony Memorial Health Centers Michigan City Indiana United States 46360
82 Saint Joseph Regional Medical Center - Plymouth Campus Plymouth Indiana United States 46544
83 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
84 Memorial Hospital of South Bend South Bend Indiana United States 46601
85 McFarland Clinic, P.C. Ames Iowa United States 50010
86 St. Luke's Hospital Cedar Rapids Iowa United States 52402
87 Cedar Rapids Oncology Associates Cedar Rapids Iowa United States 52403
88 Mercy Cancer Center at Mercy Medical Center Cedar Rapids Iowa United States 52403
89 Genesis Regional Cancer Center at Genesis Medical Center Davenport Iowa United States 52803
90 Genesis Medical Center - West Campus Davenport Iowa United States 52804
91 Mercy Capitol Hospital Des Moines Iowa United States 50307
92 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
93 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
94 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
95 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
96 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
97 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316
98 Wendt Regional Cancer Center at Finley Hospital Dubuque Iowa United States 52001
99 Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa United States 52242
100 Siouxland Regional Cancer Center Sioux City Iowa United States 51101-1733
101 Siouxland Hematology-Oncology Associates Sioux City Iowa United States 51101
102 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
103 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
104 Medical Oncology and Hematology Associates - West Des Moines West Des Moines Iowa United States 50266
105 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
106 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
107 Cancer Center of Kansas, P.A. - El Dorado El Dorado Kansas United States 67042
108 Cancer Center of Kansas - Kingman Kingman Kansas United States 67068
109 Southwest Medical Center Liberal Kansas United States 67901
110 Cancer Center of Kansas - Newton Newton Kansas United States 67114
111 Cancer Center of Kansas, P.A. - Parsons Parsons Kansas United States 67357
112 Pratt Cancer Center of Kansas Pratt Kansas United States 67124
113 Cancer Center of Kansas - Salina Salina Kansas United States 67042
114 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
115 Associates in Womens Health Wichita Kansas United States 67203
116 Cancer Center of Kansas, P.A. Wichita Kansas United States 67208
117 Cancer Center of Kansas, P.A. - Wichita Wichita Kansas United States 67214
118 CCOP - Wichita Wichita Kansas United States 67214
119 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
120 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
121 Central Maine Medical Center Lewiston Maine United States 04240
122 Maine Center for Cancer Medicine and Blood Disorders - Scarborough Scarborough Maine United States 04074
123 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21287-8936
124 Union Hospital Cancer Center at Union Hospital Elkton MD Maryland United States 21921
125 Lawrence Memorial Hospital of Medford Medford Massachusetts United States 02155
126 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48100
127 Borgess Medical Center Kalamazooaa Michigan United States 49001
128 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
129 West Michigan Cancer Center Kalamazoo Michigan United States 49007
130 William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan United States 48073
131 Fairview Ridges Hospital Burnsville Minnesota United States 55337
132 Mercy Hospital Coon Rapids Minnesota United States 55433
133 Fairview Southdale Hospital Edina Minnesota United States 55435
134 Mercy and Unity Cancer Center at Mercy and Unity Hospitals Fridley Minnesota United States 55432
135 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
136 Meeker County Memorial Hospital Litchfield Minnesota United States 55355
137 St. John's Hospital Maplewood Minnesota United States 55109
138 Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
139 Hennepin County Medical Center - Minneapolis Minneapolis Minnesota United States 55415
140 Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota United States 55417
141 Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale Minnesota United States 55422
142 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
143 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
144 Cancer Care Center at Regions Hospital Saint Paul Minnesota United States 55101
145 Saint Francis Cancer Center Shakopee Minnesota United States 55379
146 St. Joseph's Hospital St Paul Minnesota United States 55102
147 Park Nicollet Clinic St. Louis Park Minnesota United States 55416
148 United Hospital St. Paul Minnesota United States 55102
149 Ridgeview Medical Center Waconia Minnesota United States 55387
150 Woodwinds Hospital Woodbury Minnesota United States 55125
151 Missouri Cancer Associates Columbia Missouri United States 65201
152 CCOP - Kansas City Kansas City Missouri United States 64131
153 St. John's Regional Health Center Springfield Missouri United States 65804
154 Hulston Cancer Center at Cox Medical Center South Springfield Missouri United States 65807
155 St. Anthony's Cancer Center St. Louis Missouri United States 63128
156 CCOP - Montana Cancer Consortium Billings Montana United States 59101
157 Deaconess Billings Clinic - Downtown Billings Montana United States 59101
158 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
159 St. Vincent Healthcare Billings Montana United States 59101
160 Deaconess Billings Clinic Cancer Center Billings Montana United States 59107
161 Bozeman Deaconess Hospital Bozeman Montana United States 59715
162 St. James Community Hospital Butte Montana United States 59701
163 Great Falls Clinic Great Falls Montana United States 59405
164 Sletten Regional Cancer Institute Great Falls Montana United States 59405
165 St. Peter's Hospital Helena Montana United States 59601
166 Kalispell Regional Medical Center Kalispell Montana United States 59901
167 Eastern Montana Cancer Center Miles City Montana United States 59301
168 Community Medical Center Missoula Montana United States 59801
169 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59802
170 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
171 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
172 Cancer Institute of New Jersey at the Cooper University Hospital Camden New Jersey United States 08103
173 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07018-1095
174 CCOP - Northern New Jersey Hackensack New Jersey United States 07601
175 Cancer Institute of New Jersey at Hamilton Hamilton New Jersey United States 08690
176 Fox Chase Virtua Health Cancer Program - Marlton Marlton New Jersey United States 08053
177 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey United States 08903
178 Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees New Jersey United States 08043
179 Roswell Park Cancer Institute Buffalo New York United States 14263
180 Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls New York United States 12801
181 Lipson Cancer and Blood Center at Rochester General Hospital Rochester New York United States 14621
182 James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York United States 14642
183 Long Island Cancer Center at Stony Brook University Hospital Stony Brook New York United States 11794
184 CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York United States 13057
185 Veterans Affairs Medical Center - Syracuse Syracuse New York United States 13210
186 Community General Hospital of Greater Syracuse Syracuse New York United States 13215
187 Randolph Hospital Asheboro North Carolina United States 27203
188 Batte Cancer Center at Northeast Medical Center Concord North Carolina United States 28025
189 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
190 John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital Eden North Carolina United States 27288
191 Wayne Memorial Hospital, Incorporated Goldsboro North Carolina United States 27534
192 Moses Cone Regional Cancer Center at Wesley Long Community Hospital Greensboro North Carolina United States 27401
193 Lenoir Memorial Cancer Center Kinston North Carolina United States 28501
194 Annie Penn Cancer Center Reidsville North Carolina United States 27320
195 Rutherford Hospital Rutherfordton North Carolina United States 28139
196 Wilson Medical Center Wilson North Carolina United States 27893
197 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157
198 Bismarck Cancer Center Bismarck North Dakota United States 58501
199 Medcenter One Health System Bismarck North Dakota United States 58501
200 Mid Dakota Clinic, P.C. Bismarck North Dakota United States 58501
201 St. Alexius Medical Center Bismarck North Dakota United States 58501
202 Akron City Hospital at Summa Health System Akron Ohio United States 44304
203 St. Elizabeth Boardman Cancer Center Boardman Ohio United States 44512
204 Adena Regional Medical Center Chillicothe Ohio United States 54601
205 Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University Cleveland Ohio United States 44106
206 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
207 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus Ohio United States 43210
208 Riverside Methodist Hospital Cancer Care Columbus Ohio United States 43214
209 CCOP - Columbus Columbus Ohio United States 43215
210 Grant Riverside Cancer Services Columbus Ohio United States 43215
211 Mount Carmel West Hospital Columbus Ohio United States 43222
212 Doctors Hospital at Ohio Health Columbus Ohio United States 43228
213 Grandview Hospital Dayton Ohio United States 45405
214 Good Samaritan Hospital Dayton Ohio United States 45406
215 Miami Valley Hospital Dayton Ohio United States 45409
216 Samaritan North Cancer Care Center Dayton Ohio United States 45415
217 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
218 CCOP - Dayton Dayton Ohio United States 45429
219 Grady Memorial Hospital Delaware Ohio United States 43015
220 Community Oncology Group - Independence Independence Ohio United States 44131
221 Charles F. Kettering Memorial Hospital Kettering Ohio United States 45429
222 Fairfield Medical Center Lancaster Ohio United States 43130
223 Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio United States 45750
224 Middletown Regional Hospital Middletown Ohio United States 45044
225 Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio United States 43055
226 Mercy Medical Center Oncology Unit Springfield Ohio United States 45504
227 Community Hospital of Springfield and Clark County Springfield Ohio United States 45505
228 UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio United States 45373
229 St. Joseph Health Care Center Warren Ohio United States 44484
230 Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital Westerville Ohio United States 43081
231 Cleveland Clinic - Wooster Wooster Ohio United States 44691
232 Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio United States 45385
233 St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown Youngstown Ohio United States 44510
234 Genesis - Good Samaritan Hospital Zanesville Ohio United States 43701
235 Oklahoma University Medical Center Oklahoma City Oklahoma United States 73104
236 Legacy Mount Hood Medical Center Glesham Oregon United States 97030
237 Cancer Treatment Center at Merle West Medical Center Klamath Falls Oregon United States 97601
238 Providence Milwaukie Hospital Milwaukie Oregon United States 97222
239 Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center Portland Oregon United States 97210
240 Providence Cancer Center at Providence Portland Medical Center Portland Oregon United States 97213
241 CCOP - Columbia River Oncology Program Portland Oregon United States 97225
242 Providence St. Vincent Medical Center Portland Oregon United States 97225
243 Institute of Oncology at Vilnius University Portland Oregon United States 97227
244 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
245 Geisinger Medical Center Danville Pennsylvania United States 17822-2001
246 Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
247 Central Pennsylvania Hematology and Medical Oncology Associates, PC Lemoyne Pennsylvania United States 17043
248 Lewistown Hospital Lewistown Pennsylvania United States 17044
249 Riddle Memorial Hospital Media Pennsylvania United States 19063
250 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
251 Joan Karnell Cancer Center at Pennsylvania Hospital Philadelphia Pennsylvania United States 19107
252 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107
253 Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburg Pennsylvania United States 15213
254 Pottstown Memorial Regional Cancer Center Pottstown Pennsylvania United States 19464
255 Geisinger Medical Group State College Pennsylvania United States 16801
256 Mount Nittany Medical Center State College Pennsylvania United States 16803
257 Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania United States 18711
258 Rhode Island Hospital Providence Rhode Island United States 02903
259 Miriam Hospital at Lifespan Providence Rhode Island United States 02906
260 Rose Ramer Cancer Clinic at Anderson Area Medical Center Anderson South Carolina United States 29621
261 Roper St. Francis Healthcare - Roper Hospital Charleston South Carolina United States 29401
262 Bon Secours St. Francis Health System Greenville South Carolina United States 29601
263 Greenville Hospital System Cancer Center Greenville South Carolina United States 29605
264 CCOP - Greenville Greenville South Carolina United States 29615
265 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
266 CCOP - Upstate Carolina Spartanburg South Carolina United States 29304
267 Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls South Dakota United States 57104
268 Avera McKennan Hospital and University Health Center Sioux Falls South Dakota United States 57105
269 Medical X-Ray Center Sioux Falls South Dakota United States 57105
270 Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville Tennessee United States 37232
271 Danville Regional Medical Center Danville Virginia United States 24541
272 Providence Cancer Center at Sacred Heart Medical Center Spokane Washington United States 99204
273 Providence Cancer Center at Holy Family Hospital Spokane Washington United States 99207
274 Cancer Center at Southwest Washington Medical Center Vancouver Washington United States 98668
275 West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston West Virginia United States 25304
276 St. Mary's Medical Center Huntington West Virginia United States 25702
277 Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown West Virginia United States 26506
278 Fox Valley Hematology and Oncology Appleton Wisconsin United States 54911-3496
279 Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
280 UW Health Oncology Madison Wisconsin United States 53715
281 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792
282 Marshfield Clinic - Marshfield Center Marshfield Wisconsin United States 54449
283 Medical College of Wisconsin Cancer Center Milwaukee Wisconsin United States 53226
284 University of Wisconsin Cancer Center at Aspirus Wausau Hospital Wausau Wisconsin United States 54401
285 Welch Cancer Center Sheridan Wyoming United States 82801

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Dean Bajorin, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00014534
Other Study ID Numbers:
  • CALGB-90104
  • P30CA008748
  • CALGB-90104
  • MSKCC-00138
  • NCI-G01-1935
  • CDR0000068554
First Posted:
Jun 10, 2003
Last Update Posted:
Jul 14, 2016
Last Verified:
Jul 1, 2016

Study Results

No Results Posted as of Jul 14, 2016