Combination Chemotherapy Plus Cetuximab in Treating Patients With Liver Metastases From Colorectal Cancer



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2004

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A Phase II Study Of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), Leucovorin (CF), and Cetuximab (C225) For Patients With Unresectable Hepatic Metastases From Metastatic Adenocarcinoma Of The Colon Or Rectum

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells
and either kill them or deliver tumor-killing substances to them without harming normal
cells. Combining chemotherapy with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
with cetuximab works in treating patients with unresectable liver metastases from colorectal
cancer.

OBJECTIVES:

- Determine the surgical resectability rate of patients with unresectable hepatic
metastases secondary to metastatic colorectal adenocarcinoma treated with oxaliplatin,
fluorouracil, leucovorin calcium, and cetuximab.

- Determine the response rate and overall survival of patients treated with this regimen.

- Determine the quality of life of patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1
and 8. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2
hours on day 1 and fluorouracil IV continuously on days 1-2. Treatment repeats every 2 weeks
in the absence of disease progression or unacceptable toxicity, for a minimum of 12 courses
or until deemed to have resectable disease.

Quality of life is assessed at baseline and prior to each treatment course.

Patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 67-73 patients will be accrued for this study within 4 years.

DISEASE CHARACTERISTICS:

- History of completely resected primary adenocarcinoma of the colon or rectum

- No gross or microscopic evidence of residual disease

- Liver metastases, meeting 1 of the following criteria:

- Not optimally resectable

- Requires resection of all 3 major hepatic veins, the portal vein bifurcation, or
the retrohepatic vena cava

- Includes the main right or main left portal vein and the main hepatic vein of
the opposite lobe

- Requires more than a right or left trisegmentectomy

- At least 6 metastatic lesions distributed diffusely in both lobes of the liver

- Measurable disease

- At least 1 measurable lesion ≥ 20 mm

- No evidence of extrahepatic metastases by physical examination or x-ray

- No previously resected extrahepatic metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Hemoglobin ≥ 9 g/dL

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

- Platelet count ≥ 100,000/mm^3

Hepatic

- AST ≤ 3 times upper limit of normal (ULN)

- Bilirubin ≤ ULN

- No preexisting chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis)
that would preclude surgical resection of metastases

Renal

- Creatinine ≤ 1.5 times ULN

Cardiovascular

- No myocardial infarction within the past 6 months

- No clinical evidence of congestive heart failure

- No New York Heart Association class III-IV heart disease

- No significant cardiac disease

- No uncontrolled hypertension

- No unstable angina

- No congestive heart failure

- No uncontrolled arrhythmias

Gastrointestinal

- Adequate oral nutrition with estimated caloric intake of ≥ 1,500 calories/day

- No severe anorexia or frequent nausea and/or vomiting

- No history of gastrointestinal bleeding that has not been appropriately addressed

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to tolerate major surgery

- No prior allergic reaction or known sensitivity to chimerized or murine monoclonal
antibody therapy

- No documented presence of human anti-mouse antibodies

- No known allergy to other platinum compounds

- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer, carcinoma in situ, or tumors associated with less than 10% probability of
death within 5 years of diagnosis

- No preexisting neuropathy ≥ grade 2

- No symptomatic pulmonary fibrosis or interstitial pneumonitis

- No uncontrolled bacterial or viral infection

- HIV negative

- No fungal infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No colony-stimulating factors within 24 hours of day 1 of each course

- No concurrent immunotherapy

Chemotherapy

- At least 1 year since prior adjuvant systemic fluorouracil with or without levamisole
or with or without leucovorin calcium

- No prior oxaliplatin

- No prior systemic chemotherapy for metastatic disease

- No prior chemoembolization for metastatic disease

- No prior hepatic artery infusion chemotherapy for metastatic disease

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- At least 12 months since prior adjuvant radiotherapy

- Prior radiofrequency ablation allowed

- No prior radiotherapy to the liver

- No prior radiotherapy to more than 25% of the bone marrow

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

- More than 21 days since prior abdominal exploration (with or without intestinal
resection)

Other

- No prior anti-EGFR-directed therapy

- Prior cryotherapy allowed

- No oral cryotherapy on day 1 of each course
We found this trial at
162
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St. Louis Park, Minnesota 55416
1388
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St. Louis Park, MN
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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...
2336
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Allentown, PA
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1920 Libal Street
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
1646
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Green Bay, WI
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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...
1264
mi
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Sioux Falls, SD
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825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
1435
mi
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Wichita, KS
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777 Kimole Ln
Adrian, Michigan 49221
517-265-0900
Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
1899
mi
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Adrian, MI
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1275
mi
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Alexandria, MN
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
1450
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Ames, IA
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Anderson, South Carolina 29621
2227
mi
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Anderson, SC
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Aurora, Illinois 60507
1708
mi
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Aurora, IL
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8111 South Emerson Avenue
Beech Grove, Indiana 46237
(317) 528-5000
St. Francis Hospital and Health Centers - Beech Grove Campus A trusted leader in providing...
1872
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Beech Grove, IN
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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...
1273
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Bemidji, MN
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1609
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Bettendorf, IA
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500 N 8th St
Bismarck, North Dakota 58501
(701) 222-6100
Bismarck Cancer Center The Bismarck Cancer Center (BCC) is a joint venture between Sanford Health...
1010
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Bismarck, ND
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720 E Rosser Ave
Bismarck, North Dakota 58501
(701) 323-6741
Medcenter One Hospital Cancer Care Center Sanford Health is an integrated health system headquartered in...
1010
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Bismarck, ND
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900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
1010
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900 East Broadway
Bismarck, North Dakota 58501
701.530.7000
St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
1013
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Bismarck, ND
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2200 E Washington St,
Bloomington, Illinois 61701
(309) 662-3311
St. Joseph Medical Center Located in Bloomington, Illinois, OSF St. Joseph Medical Center is a...
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Bloomington, IL
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960 W. Wooster
Bowling Green, Ohio 43402
419-352-9498
Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
1932
mi
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Bowling Green, OH
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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...
1395
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Burnsville, MN
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210 W Walnut St
Canton, Illinois 61520
(309) 647-5240
Graham Hospital At Graham Hospital, we have a proud and rich history of serving the...
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Canton, IL
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1454 North County Road 2050
Carthage, Illinois 62321
(217) 357-8500
Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
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525 10th St SE
Cedar Rapids, Iowa 52403
(319) 363-8303
Cedar Rapids Oncology Associates Oncology Associates at Mercy Medical Center in Cedar Rapids (also known...
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Chanute, KS
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11850 Blackfoot St. NW Suite 130
Coon Rapids, Minnesota 55433
763-236-0808
Mercy and Unity Cancer Center at Mercy Hospital The Virginia Piper Cancer Institute - Mercy...
1385
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Dayton, Ohio 45406
1956
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Dayton, OH
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1 Wyoming St
Dayton, Ohio 45409
(937) 208-2300
1961
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Dayton, OH
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1957
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Dayton, OH
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Dayton, Ohio 45420
1959
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Dayton, OH
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405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
1958
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9000 North Main Street
Dayton, Ohio 45415
(937) 734-5800
Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
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Des Moines, Iowa 50307
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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1221 Pleasant St
Des Moines, Iowa 50309
(515) 241-4141
John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
(515) 282-2921
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
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Des Moines, IA
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411 Laurel St New Visions
Des Moines, Iowa 50314
(515) 247-3970
Medical Oncology and Hematology Associates at Mercy Cancer Center When it comes to cancer care,...
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411 Laurel Street
Des Moines, Iowa 50314
(515) 247-3121
Mercy Cancer Center at Mercy Medical Center - Des Moines When it comes to cancer...
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2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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Duluth, Minnesota 55805
1411
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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502 E 2nd St,
Duluth, Minnesota 55805
(218) 727-8762
Miller - Dwan Medical Center Essentia Health-Duluth, located in the Miller-Dwan building, is a 165-bed...
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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...
1390
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Edina, MN
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700 West Central
El Dorado, Kansas 67042
(316) 889-0099
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
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El Dorado, KS
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Escanaba, Michigan 49431
1733
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Escanaba, MI
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101 S Major St
Eureka, Illinois 61530
(309) 467-2371
Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
1692
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Eureka, IL
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820 4th Street North
Fargo, North Dakota 58122
(701) 234-6292
CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
1172
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Fargo, ND
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801 Broadway N
Fargo, North Dakota 58102
(701) 234-2000
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1236
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Fergus Falls, MN
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200 West Pearl Street
Findlay, Ohio 45840
419-424-0380
Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
1944
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Findlay, OH
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Fredericksburg, Virginia 22401
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Fremont, Ohio 43420
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Fremont, OH
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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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Fridley, MN
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Galesburg, Illinois 61401
1634
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Galesburg, IL
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3315 N. Seminary Street
Galesburg, Illinois 61401
(309) 344-1000
Galesburg Clinic, PC OSF Galesburg Clinic, located on the OSF St. Mary Medical Center campus,...
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960 S. Columbia Rd.
Grand Forks, North Dakota 58201
701-780-5400
Altru Cancer Center at Altru Hospital From chemotherapy and radiation therapy to personal holistic services,...
1168
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Grand Forks, ND
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1117 29th St S Ste 500
Great Falls, Montana 59405
(406) 731-8100
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Green Bay, WI
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Green Bay, WI
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615 N. Promenade Street
Havana, Illinois 62644
(309) 543-4431
Mason District Hospital Mason District Hospital is dedicated to providing superior healthcare close to home...
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Hopedale, Illinois 61747
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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...
1341
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1721 S Stephenson Ave
Iron Mountain, Michigan 49801
(906) 774-1313
Dickinson County Healthcare System The vision of Dickinson County Healthcare System is to provide quality...
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Jacksonville, Florida 32216
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Jacksonville, FL
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Joliet, IL
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Kettering, OH
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Kewanee, Illinois 61443
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750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
Cancer Center of Kansas, PA - Kingman Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Kingman, KS
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Lambertville, MI
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Liberal, Kansas 67901
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Lichfield, Minnesota 55355
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1001 Bellefontaine Ave
Lima, Ohio 45804
(419) 228-3335
Lima Memorial Hospital We also offer an extended network of primary care, pediatric and specialist...
1933
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Lima, OH
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525 E Grant St
Macomb, Illinois 61455
(309) 833-4101
McDonough District Hospital McDonough District Hospital is centered in Macomb, Illinois, home to Division 1...
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Macomb, IL
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Maplewood, Minnesota 55109
1401
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Maplewood, MN
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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...
1402
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Maplewood, MN
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3100 Shore Dr.
Marinette, Wisconsin 54143
715.735.6621
Bay Area Cancer Care Center at Bay Area Medical Center The Bay Area Cancer Care...
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Marinette, WI
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1000 4th St SW
Mason City, Iowa 50401
(641) 428-7000
Mercy Cancer Center at Mercy Medical Center - North Iowa In the late 1800s, the...
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5805 Monclova Rd
Maumee, Ohio 43537
(419) 891-5600
Northwest Ohio Oncology Center The Northwest Ohio Oncology Center, located on the campus of ProMedica...
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Maumee, OH
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Maumee, Ohio 43537
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301 W Homer St
Michigan City, Indiana 46360
(219) 879-8511
Saint Anthony Memorial Health Centers Franciscan St. Anthony Health - Michigan City is proud to...
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Michigan City, IN
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Middletown, Ohio 45044
1958
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Middletown, OH
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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...
1392
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Minneapolis, MN
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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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Minneapolis, MN
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Mobile, Alabama 36607
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Mobile, AL
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Moline, Illinois 61265
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Moline, IL
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Moline, IL
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Monroe, Michigan 48162
1929
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Monroe, MI
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800 Stewart Rd
Monroe, Michigan 48162
(734) 242-7902
Community Cancer Center of Monroe The Monroe Cancer Center, a joint venture between the Barbara...
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Monroe, MI
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1278
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Montevideo, MN
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720 Medical Center Drive
Newton, Kansas 67114
(316) 282-0888
Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Newton, KS
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Normal, Illinois 61761
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Normal, IL
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1304 Franklin Avenue
Normal, Illinois 61761
309.454.1400
BroMenn Regional Medical Center Advocate BroMenn Medical Center is a general medical and surgical hospital...
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Normal, IL
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Oconto Falls, Wisconsin 54154
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Oconto Falls, WI
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1365
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Omaha, NE
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6901 N 72nd St
Omaha, Nebraska 68122
(402) 572-2121
Immanuel Medical Center Welcome to Alegent Creighton Immanuel Medical Center. Our campus, located in North...
1359
mi
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Omaha, NE
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7500 Mercy Rd
Omaha, Nebraska 68124
(402) 398-6060
Alegent Health Cancer Center at Bergan Mercy Medical Center Welcome to Alegent Creighton Health Bergan...
1362
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Omaha, NE
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601 N 30th St
Omaha, Nebraska 68131
(402) 449-4000
Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
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Omaha, NE
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Oregon, Ohio 43616
1933
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Oregon, OH
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2600 Navarre Ave
Oregon, Ohio 43616
(419) 578-7555
1933
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Oregon, OH
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