Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/23/2018
Start Date:July 2005
End Date:April 2015

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Phase II Study of Treatment Selection Based Upon Tumor Thymidylate Synthase Expression in Previously Untreated Patients With Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, leucovorin, and
fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can
block tumor growth in different ways. Some block the ability of tumor cells to grow and
spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the
tumor. Giving bevacizumab together with combination chemotherapy may be a better way to block
tumor growth. Studying the amount of an enzyme found in the tumor may help doctors plan the
best treatment.

PURPOSE: This randomized phase II trial is studying giving bevacizumab, oxaliplatin, and
irinotecan or giving bevacizumab, oxaliplatin, leucovorin, and fluorouracil in treating
patients with metastatic or recurrent colorectal cancer.

OBJECTIVES:

- Compare the response rate (complete and partial), progression-free survival, and overall
survival of patients with previously untreated metastatic or locally recurrent
colorectal adenocarcinoma with high vs low thymidylate synthase (TS) expression treated
with fluorouracil, leucovorin calcium, oxaliplatin, and bevacizumab or irinotecan,
oxaliplatin, and bevacizumab.

- Compare the toxicity of these regimens in these patients.

- Correlate gene expression with response rates in patients treated with these regimens.

- Correlate gene expression with toxicity of these regimens in these patients.

- Correlate dihydropyrimidine dehydrogenase, thymidine phosphorylase, and mammalian
excision repair cross complementary protein expression with antitumor response in
patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
thymidylate synthase (TS) expression levels (high vs low or indeterminate). Patients with
high TS expression are randomized to 1 of 2 treatment arms (Arms A or B). Patients with low
or indeterminate TS expression are assigned to Arm C.

- Arm A: Patients receive bevacizumab IV over 30-90 minutes followed by oxaliplatin IV
over 2 hours and irinotecan IV over 90 minutes on days 1 and 15.

- Arm B: Patients receive bevacizumab and oxaliplatin as in arm A, leucovorin calcium IV
over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on
days 1 and 15.

- Arm C: Patients receive bevacizumab, oxaliplatin, leucovorin calcium, and fluorouracil
as in arm B.

In all arms, courses repeat every 28 days in the absence of unacceptable toxicity or disease
progression.

Patients are followed up every 3 months for 2 years and then every 6 months for 2 years from
the date of study registration.

INCLUSION:

- Metastatic or locally recurrent colorectal adenocarcinoma

- Measurable disease

- At least 2 formalin-fixed paraffin embedded core needle biopsies OR fine needle
aspirate containing a minimum of 3 clusters of malignant cells and fixed tissue from
the previous biopsy

- If no tissue samples are available the patient must be willing to undergo biopsy of a
metastatic site

- Age 18 and over

- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 unless patient is
receiving full-dose anticoagulants AND the following criteria are met:

- In-range INR (usually between 2 and 3) AND on a stable dose of warfarin or low
molecular weight heparin

- No active bleeding or pathological condition that is associated with a high risk
of bleeding

- Partial thromboplastin time (PTT) < 1.5 times upper limit of normal (ULN)

- Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 3 times ULN

- Bilirubin ≤ 1.5 times ULN

- Creatinine ≤ 1.8 mg/dL

- Meets 1 of the following criteria:

- Protein negative on urine dipstick

- Urine protein/creatinine ratio < 1.0

- Less than 2 g protein on 24-hour urine collection

- Patients with a history of hypertension must meet the following criteria:

- Blood pressure < 150/90 mm Hg

- Stable regimen of anti-hypertensive therapy

- More than 28 days since prior major or open surgery

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- Prior non-colorectal malignancies are allowed provided the following criteria are met:

- No current clinical evidence of persistent or recurrent disease

- No active therapy for non-colorectal malignancy, including hormonal therapy

EXCLUSION:

- Pregnant or nursing

- Arterial thromboembolic events within the past 6 months, including the following:

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina pectoris

- Myocardial infarction

- Symptomatic arrhythmia

- Symptomatic congestive heart failure

- Clinically significant peripheral artery disease

- New York Heart Association class III or IV heart disease

- Serious nonhealing wound, ulcer, or bone fracture within the past 28 days

- Significant traumatic injury within the past 28 days

- Neuropathy ≥ grade 2

- Ongoing or active infection

- Concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

- Prior chemotherapy for metastatic disease. Adjuvant therapy completed at least 12
months before first evidence of metastasis allowed

- Cardiovascular, renal, hepatic, or other nonmalignant systemic disease that would
preclude study therapy
We found this trial at
110
sites
100 Provena Way
Kankakee, Illinois 60914
815.937.8780
Provena St. Mary's Regional Cancer Center - Kankakee For over 20 years, Presence St. Mary's...
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Lehigh Valley Hospital provides a...
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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Chicago, IL
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2500 Metrohealth Dr # C2100
Cleveland, Ohio 44109
(216) 778-5802
MetroHealth Cancer Care Center at MetroHealth Medical Center At the MetroHealth Cancer Care Center, we...
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3535 Olentangy River Road
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
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1719 East 19th Avenue
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
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1376 Mowry Road
Gainesville, Florida 32610
(352) 273-8010
University of Florida Shands Cancer Center We are the University of Florida Health Cancer Center
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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700 Potomac St
Aurora, Colorado 80012
(303) 363-7200
Aurora Presbyterian Hospital At The Medical Center of Aurora and Centennial Medical Plaza, we treat...
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1233 34th St NW
Bemidji, Minnesota 56601
(218) 333-5000
MeritCare Bemidji Sanford Health is an integrated health system headquartered in the Dakotas and is...
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Chicago, Illinois 60657
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676 N St Clair St #2140
Chicago, Illinois 60611
(312) 664-5400
Hematology and Oncology Associates Northwestern Medical Faculty Foundation (the Foundation) is a premier, multi-specialty physician...
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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11100 Euclid Avenue
Cleveland, Ohio 44106
216.844.8797
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2222 N. Nevada Avenue
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(719) 776-5000
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111 S Grant Avenue
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(614) 566-4321
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Columbus, Ohio 43228
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793 West State Street
Columbus, Ohio 43222
614-234-5000
Mount Carmel Health - West Hospital Located near downtown Columbus, Mount Carmel West is the...
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
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11850 Blackfoot St. NW Suite 130
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2300 N. Edward Street
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217-876-8121
Decatur Memorial Hospital Cancer Care Institute An American flag bearing only 48 stars waved above...
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561 W. Central Avenue
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2525 S Downing St
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11600 W 2nd Pl
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(720) 321-0000
St. Anthony Central Hospital The St. Anthony Medical Campus in Lakewood combines our heritage of...
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4567 E 9th Ave
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(303) 320-2121
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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600 East Blvd
Elkhart, Indiana 46515
(574) 294-2621
Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
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820 4th Street North
Fargo, North Dakota 58122
(701) 234-6292
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550 Osborne Road
Fridley, Minnesota 55432
763-236-5000
Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
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2635 North 7th Street
Grand Junction, Colorado 81501
970-298-CARE (2273)
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1801 16th St
Greeley, Colorado 80631
(970) 352-4121
North Colorado Medical Center NCMC is a fully accredited, private, non-profit facility licensed to operate...
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1095 Minnesota 15
Hutchinson, Minnesota 55350
(320) 234-5000
Hutchinson Area Health Care Hutchinson Health is a team of medical professionals and support staff...
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Indianapolis, Indiana 46202
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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Kokomo, Indiana 46904
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1007 LINCOLNWAY
La Porte, Indiana 46350
219.326.1234
Center for Cancer Therapy at LaPorte Hospital and Health Services United in our mission, the...
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401 N Ewing St
Lancaster, Ohio 43130
(740) 687-8000
Fairfield Medical Center We are people you know offering care you trust. Serving more than...
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1800 Hollister Drive, Suite 112
Libertyville, Illinois 60048
847-367-6781
North Shore Oncology and Hematology Associates, Limited - Libertyville Welcome to North Shore Oncology and...
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730 W Market St
Lima, Ohio 45801
(419) 227-3361
St. Rita's Medical Center Welcome to St. Rita's Medical Center. As the region's leader in...
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4600 Valley Rd # 336
Lincoln, Nebraska 68510
(402) 483-2827
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7700 S Broadway
Littleton, Colorado 80122
(303) 730-8900
Littleton Adventist Hospital On April 3, 1989 Littleton Adventist Hospital opened its doors to the...
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10101 RidgeGate Pkwy
Lone Tree, Colorado 80124
720) 225-1000
Sky Ridge Medical Center HealthONE is the largest healthcare system in the metro Denver area...
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1950 Mountain View Ave
Longmont, Colorado 80501
303.651.5111
Hope Cancer Care Center at Longmont United Hospital Patients treated at the Hope Cancer Care...
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2000 N Boise Ave
Loveland, Colorado 80538
(970) 669-4640
McKee Medical Center Through the years, McKee has led the way in health care innovation....
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1580 Beam Ave
Maplewood, Minnesota 55109
(651) 779-7978
Minnesota Oncology - Maplewood At Minnesota Oncology, we join together with you in a firm...
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1575 Beam Avenue
Maplewood, Minnesota 55109
651-232-7970
HealthEast Cancer Care at St. John's Hospital From the moment patients and visitors walk into...
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401 Matthew St
Marietta, Ohio 45750
(740) 376-5000
Strecker Cancer Center at Marietta Memorial Hospital The Memorial Health System's Strecker Cancer Center combines...
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90 Brick Rd
Marlton, New Jersey 08053
(856) 355-6000
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Virtua collaborates with Fox...
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701 Park Ave
Minneapolis, Minnesota 55415
(612) 873-3000
Hennepin County Medical Center - Minneapolis Hennepin Healthcare System, Inc. operates Hennepin County Medical Center...
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800 E 28th St
Minneapolis, Minnesota 55407
612-863-4000
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital As the largest hospital in the...
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5215 Holy Cross Parkway
Mishawaka, Indiana 46545
574-335-5000
Saint Joseph Regional Medical Center Saint Joseph Regional Medical Center is a not-for-profit, multi-hospital health...
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1330 Coshocton Ave
Mount Vernon, Ohio 43050
(740) 393-9000
Knox Community Hospital A community-owned, 115-bed, not-for-profit hospital located in Mount Vernon, Ohio (approximately 40...
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1324 5th St N
New Ulm, Minnesota 56073
(507) 217-5000
New Ulm Medical Center New Ulm Medical Center is a nonprofit hospital and clinic serving...
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1320 West Main Street
Newark, Ohio 43055
(740) 348-4475
Licking Memorial Cancer Care Program at Licking Memorial Hospital Our Cancer Program has been approved...
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8915 W Golf Rd
Niles, Illinois 60714
(847) 827-9060
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Omaha, Nebraska 68130
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6901 N 72nd St
Omaha, Nebraska 68122
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Immanuel Medical Center Welcome to Alegent Creighton Immanuel Medical Center. Our campus, located in North...
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7500 Mercy Rd
Omaha, Nebraska 68124
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Alegent Health Cancer Center at Bergan Mercy Medical Center Welcome to Alegent Creighton Health Bergan...
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601 N 30th St
Omaha, Nebraska 68131
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1001 PENNSYLVANIA AVENUE
Ottumwa, Iowa 52501
641.684.2300
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9395 Crown Crest Blvd
Parker, Colorado 80138
(303) 269-4000
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1121 Kinneys Ln
Portsmouth, Ohio 45662
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Spruce St
Reading, Pennsylvania 19611
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3435 W Broadway Ave
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1092 Lydia Dr
Saint Joseph, Michigan 49085
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Saint Louis Park, Minnesota 55416
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3931 Louisiana Ave S
Saint Louis Park, Minnesota 55426
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333 Smith Ave
Saint Paul, Minnesota 55102
(651) 241-8000
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1455 St. Francis Ave.
Shakopee, Minnesota 55379
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801 5th St
Sioux City, Iowa 51104
(712) 279-2010
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230 Nebraska St.
Sioux City, Iowa 51101
712-252-0088
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2720 Stone Park Blvd
Sioux City, Iowa 51104
(712) 279-3500
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Sioux Falls, South Dakota 57117
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South Bend, Indiana 46601
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615 N Michigan St
South Bend, Indiana 46601
(574) 647-1000
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100 Medical Center Drive
Springfield, Ohio 45504
937-523-1000
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630 Medical Dr
Stillwater, Minnesota 84010
(801) 299-2200
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Temple, Texas 76508
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