Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003764

Collaborator

National Cancer Institute (NCI) (NIH), Cancer and Leukemia Group B (Other), Southwest Oncology Group (Other)

280

Enrollment

218

Locations

1.3

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known whether combining cyclophosphamide with fludarabine is more effective than fludarabine alone in treating chronic lymphocytic leukemia.

PURPOSE: Randomized phase III trial to study the effectiveness of fludarabine with or without cyclophosphamide in treating patients who have chronic lymphocytic leukemia that has not been treated previously.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: cyclophosphamide Drug: fludarabine phosphate	Phase 3

Detailed Description

OBJECTIVES:

Compare the efficacy of fludarabine with or without cyclophosphamide in terms of complete remission rate and overall survival in patients with previously untreated B cell chronic lymphocytic leukemia (CLL).
Compare the toxicities of these 2 regimens in this patient population.
Determine whether the expression of proteins specifically implicated in the regulation of DNA damage induced apoptosis of lymphoid cells (i.e., p53; mdm2; GST; Bcl-2; Mcl-1; Bax; p27; and caspase-3) correlates with response to chemotherapy in these patients.
Determine whether there is a relationship between clinical response or resistance and differential expression of genes in the CLL cells either at initiation of therapy or following relapse and progression.
Correlate mutations in immunoglobulin heavy chain variable region genes with clinical response or resistance in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (O-II vs III-IV). Patients are randomized to one of two treatment arms.

Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5.
Arm II: Patients receive fludarabine as in arm I plus cyclophosphamide IV over 1 hour on day 1.

Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months until disease progression.

PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study over 2 to 2.5 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

Phase III Randomized Trial of Fludarabine and Cyclophosphamide Versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia

Study Start Date :

Dec 1, 1999

Actual Primary Completion Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of chronic lymphocytic leukemia (CLL) of any stage as defined by the following:
Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 within 14 days prior to study
Lymphocytes must be small to moderate size with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
Phenotypically characterized as B-CLL
Must have one of the following characteristics indicating need for chemotherapy:
Progressive marrow failure (hemoglobin less than 10 g/dL and/or platelet count less than 100,000/mm^3)
Progressive lymphocytosis with an increase of more than 50% over a 2 month period or anticipated doubling time of less than 6 months
Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly
Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy
At least 10% weight loss within 6 months of study
Extreme fatigue
Fevers greater than 100.5 degrees F for 2 weeks without evidence of infection
Night sweats without evidence of infection
No autoimmune anemia or autoimmune thrombocytopenia

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics

Hepatic:

Bilirubin no greater than 2 mg/dL unless secondary to tumor

Renal:

Creatinine no greater than 2.0 mg/dL
Creatinine clearance at least 40 mL/min if creatinine is greater than 1.5 mg/dL

Other:

No other prior or concurrent malignancy within the past 2 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
No active infection requiring oral or intravenous antibiotics
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior cytotoxic chemotherapy

Endocrine therapy:

No prior steroid treatment for CLL

Radiotherapy:

Not specified

Surgery:

Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northeast Alabama Regional Medical Center	Anniston	Alabama	United States	36207
2	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
3	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36688
4	CCOP - Western Regional, Arizona	Phoenix	Arizona	United States	85006-2726
5	Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)	Phoenix	Arizona	United States	85012
6	Veterans Affairs Medical Center - Tucson	Tucson	Arizona	United States	85723
7	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724
8	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
9	Veterans Affairs Medical Center - Little Rock (McClellan)	Little Rock	Arkansas	United States	72205
10	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010-0269
11	Rebecca and John Moores UCSD Cancer Center	La Jolla	California	United States	92093-0658
12	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033
13	Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
14	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
15	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California	United States	94553
16	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609-3305
17	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center	Orange	California	United States	92868
18	University of California Davis Cancer Center	Sacramento	California	United States	95817
19	Veterans Affairs Medical Center - San Diego	San Diego	California	United States	92161
20	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
21	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California	United States	95403
22	David Grant Medical Center	Travis Air Force Base	California	United States	94535
23	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado	United States	80010
24	Medical Center of Aurora - South Campus	Aurora	Colorado	United States	80012-0000
25	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
26	Penrose Cancer Center	Colorado Springs	Colorado	United States	80933
27	Porter Adventist Hospital	Denver	Colorado	United States	80210
28	St. Joseph Hospital	Denver	Colorado	United States	80218-1191
29	Presbyterian-St Luke's Medical Center	Denver	Colorado	United States	80218
30	Rocky Mountain Cancer Centers - Rose	Denver	Colorado	United States	80220
31	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado	United States	80224
32	Swedish Medical Center	Englewood	Colorado	United States	80110
33	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
34	Longmont United Hospital	Longmont	Colorado	United States	80501
35	St. Mary-Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
36	Rocky Mountain Cancer Centers	Thornton	Colorado	United States	80260
37	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
38	Lombardi Cancer Center at Georgetown University Medical Center	Washington	District of Columbia	United States	20007
39	MBCCOP - Howard University Cancer Center	Washington	District of Columbia	United States	20060
40	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
41	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia	United States	20422
42	Broward General Medical Center	Fort Lauderdale	Florida	United States	33316
43	Memorial Regional Hospital Comprehensive Cancer Center	Hollywood	Florida	United States	33021
44	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
45	Florida Hospital Cancer Institute	Orlando	Florida	United States	32804
46	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
47	Palm Beach Cancer Institute	West Palm Beach	Florida	United States	33401
48	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
49	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342-1701
50	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
51	MBCCOP - Hawaii	Honolulu	Hawaii	United States	96813
52	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611-4494
53	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611
54	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612
55	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
56	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
57	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
58	CCOP - Central Illinois	Decatur	Illinois	United States	62526
59	CCOP - Evanston	Evanston	Illinois	United States	60201
60	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois	United States	60141
61	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153-5500
62	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
63	West Suburban Center for Cancer Care	River Forest	Illinois	United States	60305
64	Saint Anthony Medical Center	Rockford	Illinois	United States	61108
65	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
66	Fort Wayne Medical Oncology and Hematology, Incorporated	Fort Wayne	Indiana	United States	46885-5099
67	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
68	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa	United States	52722
69	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
70	Genesis Medical Center	Davenport	Iowa	United States	52804
71	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
72	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1009
73	Kansas Cancer Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7353
74	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
75	Veterans Affairs Medical Center - Wichita	Wichita	Kansas	United States	67218
76	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky	United States	40502-2236
77	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky	United States	40536-0084
78	Baptist Hospital East - Louisville	Louisville	Kentucky	United States	40207
79	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
80	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112
81	Veterans Affairs Medical Center - New Orleans	New Orleans	Louisiana	United States	70112
82	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
83	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana	United States	71130-3932
84	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana	United States	71130
85	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
86	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland	United States	21201
87	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231
88	Tufts - New England Medical Center	Boston	Massachusetts	United States	02111
89	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
90	Cancer Research Center at Boston Medical Center	Boston	Massachusetts	United States	02118
91	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
92	University of Massachusetts Memorial Medical Center - University Campus	Worcester	Massachusetts	United States	01655
93	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan	United States	48105
94	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
95	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0912
96	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
97	Veterans Affairs Medical Center - Detroit	Detroit	Michigan	United States	48201-1932
98	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan	United States	48202
99	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
100	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
101	CCOP - Beaumont	Royal Oak	Michigan	United States	48073-6769
102	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	Saint Joseph	Michigan	United States	49085
103	Providence Cancer Institute at Providence Hospital	Southfield	Michigan	United States	48075
104	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
105	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
106	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
107	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
108	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi	United States	39531-2410
109	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
110	Veterans Affairs Medical Center - Jackson	Jackson	Mississippi	United States	39216
111	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri	United States	65201
112	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
113	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri	United States	64128
114	CCOP - Kansas City	Kansas City	Missouri	United States	64131
115	St. Louis University Hospital Cancer Center	Saint Louis	Missouri	United States	63110
116	Missouri Baptist Cancer Center	Saint Louis	Missouri	United States	63131
117	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
118	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65807
119	Barnes-Jewish Hospital	St. Louis	Missouri	United States	63110
120	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
121	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-7680
122	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
123	Veterans Affairs Medical Center - Las Vegas	Las Vegas	Nevada	United States	89106
124	Norris Cotton Cancer Center at Dartmouth Medical School	Lebanon	New Hampshire	United States	03756-0002
125	Cooper University Hospital	Camden	New Jersey	United States	08103
126	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey	United States	07019
127	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
128	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico	United States	87108-5138
129	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
130	Veterans Affairs Medical Center - Albany	Albany	New York	United States	12208
131	Albert Einstein Clinical Cancer Center	Bronx	New York	United States	10461
132	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
133	Elmhurst Hospital Center	Elmhurst	New York	United States	11373
134	Queens Cancer Center of Queens Hospital	Jamaica	New York	United States	11432
135	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
136	North Shore University Hospital	Manhasset	New York	United States	11030
137	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
138	New York Weill Cornell Cancer Center at Cornell University	New York	New York	United States	10021
139	Mount Sinai Medical Center, NY	New York	New York	United States	10029
140	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York	United States	10032
141	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
142	University Hospital at State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
143	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
144	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13217
145	Veterans Affairs Medical Center - Asheville	Asheville	North Carolina	United States	28805
146	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
147	NorthEast Oncology Associates	Concord	North Carolina	United States	28025
148	Veterans Affairs Medical Center - Durham	Durham	North Carolina	United States	27705
149	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
150	Cape Fear Valley Health System	Fayetteville	North Carolina	United States	28302-2000
151	Lenoir Memorial Hospital Cancer Center	Kinston	North Carolina	United States	28503-1678
152	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina	United States	28374
153	New Hanover Regional Medical Center	Wilmington	North Carolina	United States	28402-9025
154	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
155	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
156	Veterans Affairs Medical Center - Fargo	Fargo	North Dakota	United States	58102
157	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
158	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio	United States	45220-2288
159	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267-0501
160	MetroHealth Medical Center	Cleveland	Ohio	United States	44109
161	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195-9001
162	CCOP - Columbus	Columbus	Ohio	United States	43206
163	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
164	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428-1002
165	CCOP - Dayton	Dayton	Ohio	United States	45429
166	Oklahoma University Medical Center at University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
167	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma	United States	73104
168	Cancer Institute at Oregon Health and Science University	Portland	Oregon	United States	97201-3098
169	Veterans Affairs Medical Center - Portland	Portland	Oregon	United States	97207
170	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
171	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
172	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
173	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
174	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15236
175	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
176	Lifespan: The Miriam Hospital	Providence	Rhode Island	United States	02906
177	Veterans Affairs Medical Center - Charleston	Charleston	South Carolina	United States	29401-5799
178	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
179	CCOP - Greenville	Greenville	South Carolina	United States	29615
180	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
181	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104
182	University of Tennessee Cancer Institute	Memphis	Tennessee	United States	38103
183	Danville Radiation Therapy Center	Memphis	Tennessee	United States	38104
184	Harrington Cancer Center	Amarillo	Texas	United States	79106
185	Veterans Affairs Medical Center - Amarillo	Amarillo	Texas	United States	79106
186	Veterans Affairs Medical Center - Dallas	Dallas	Texas	United States	75216
187	Medical City Dallas Hospital	Dallas	Texas	United States	75230
188	Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390
189	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234-6200
190	University of Texas Medical Branch	Galveston	Texas	United States	77555-0565
191	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4095
192	Veterans Affairs Medical Center - Houston	Houston	Texas	United States	77030
193	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229-3900
194	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78229
195	Veterans Affairs Medical Center - Temple	Temple	Texas	United States	76504
196	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
197	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112-5550
198	Veterans Affairs Medical Center - Salt Lake City	Salt Lake City	Utah	United States	84148
199	Green Mountain Oncology Group	Bennington	Vermont	United States	05201
200	Vermont Cancer Center at University of Vermont	Burlington	Vermont	United States	05401-3498
201	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont	United States	05009
202	Martha Jefferson Hospital	Charlottesville	Virginia	United States	22902
203	Virginia Oncology Associates - Norfolk	Norfolk	Virginia	United States	23502
204	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037
205	Oncology and Hematology Associates of Southwest Virginia, Inc.	Roanoke	Virginia	United States	24014
206	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
207	Veterans Affairs Medical Center - Seattle	Seattle	Washington	United States	98108
208	Puget Sound Oncology Consortium	Seattle	Washington	United States	98109
209	CCOP - Northwest	Tacoma	Washington	United States	98405-0986
210	Madigan Army Medical Center	Tacoma	Washington	United States	98431-5000
211	St. Mary's Medical Center	Huntington	West Virginia	United States	25701
212	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54307-3453
213	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-0001
214	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin	United States	54449
215	Ministry Medical Group - Northern Region	Rhinelander	Wisconsin	United States	54501
216	McGill University	Montreal	Quebec	Canada	H2W 1S6
217	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan		Puerto Rico	00936-5067
218	Pretoria Academic Hospital	Pretoria		South Africa	0001

Sponsors and Collaborators

Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Southwest Oncology Group

Investigators

Study Chair: Ian W. Flinn, MD, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Chair: Michael R. Grever, MD, Ohio State University Comprehensive Cancer Center
Study Chair: Mohamad A. Hussein, MD, The Cleveland Clinic