Bevacizumab, Gemcitabine, and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer



Status:Completed
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2005
End Date:November 2010

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Phase II Trial of Bevacizumab, Gemcitabine, Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma

RATIONALE: 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 pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy,
such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab
together with gemcitabine and oxaliplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with
gemcitabine and oxaliplatin works in treating patients with metastatic pancreatic cancer.

OBJECTIVES:

Primary

- Determine the 6-month survival of patients with metastatic adenocarcinoma of the
pancreas treated with bevacizumab, gemcitabine, and oxaliplatin.

Secondary

- Determine the objective response rate in patients with measurable disease treated with
this regimen.

- Determine median survival, progression-free survival, time to treatment failure, and
overall survival of patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 100 minutes and bevacizumab IV over 30-90 minutes on
days 1 and 15. Patients also receive oxaliplatin IV over 120 minutes on days 2 and 16.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 2 courses of therapy beyond CR.

After completion of study treatment, patients are followed every 3-6 months for up to 5
years.

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed ductal cell or undifferentiated
adenocarcinoma of the pancreas

- Previously untreated metastatic disease

- No islet cell or acinar cell carcinoma or cystadenocarcinoma

- No invasion of adjacent organs (i.e., duodenum or stomach) or major blood vessels (
i.e., superior mesenteric artery or celiac artery)

- No CNS metastasis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 6 months

Hematopoietic

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

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10.0 g/dL

- No bleeding diathesis or uncontrolled coagulopathy

- No bleeding events within the past 6 months

Hepatic

- Bilirubin ≤ 2 times upper limit of normal (ULN) (stenting allowed)

- AST ≤ 5 times ULN

- No esophageal varices

Renal

- Creatinine ≤ 2 times ULN

- Proteinuria < 1+ by dipstick or urinalysis OR

- Protein < 1 g/24-hr urine collection

- No nephrotic syndrome

Cardiovascular

- No New York Heart Association class II-IV congestive heart failure

- No symptomatic, unstable angina, or coronary artery disease

- No uncontrolled cardiac arrhythmias

- No myocardial infarction within the past 6 months

- No uncontrolled hypertension

- No history of cerebrovascular events

- No clinically significant peripheral arterial disease

- No other clinically significant cardiac disease

Pulmonary

- No hemoptysis within the past 6 months

Immunologic

- No history of allergy or hypersensitivity to bevacizumab, oxaliplatin, or gemcitabine

- No hypersensitivity to Chinese hamster ovary cell products or other recombinant human
antibodies

- No known allergy to other platinum compounds

- No ongoing or active infection

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- No serious, non-healing wound, ulcer, or bone fracture

- No pre-existing peripheral neuropathy > grade 1

- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer, carcinoma in situ of the cervix, or prostate cancer with a Gleason score < 7

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

- No gastrointestinal bleeding within the past 6 months

- No unresolved physical trauma within the past 4 weeks

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 months since prior immunotherapy or biologic therapy

- No prior adjuvant bevacizumab

- No concurrent immunotherapy

- No concurrent colony-stimulating factors during the first course of study therapy

Chemotherapy

- Recovered from prior chemotherapy

- More than 4 months since prior adjuvant chemotherapy for completely resected disease

- At least 4 months since prior chemoradiotherapy for locally advanced disease

- More than 4 months since prior gemcitabine as a radiosensitizer or as maintenance
therapy

- No prior cytotoxic chemotherapy for metastatic disease

- No prior adjuvant oxaliplatin

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Chemotherapy

- More than 4 months since prior radiotherapy

- No prior radiotherapy to > 25% of bone marrow

- No prior radiotherapy to sole site of measurable disease unless there is
radiologically confirmed progression of the irradiated tumor

- No concurrent radiotherapy

Surgery

- More than 4 weeks since prior major surgery or trauma and recovered

- No concurrent surgery

Other

- More than 2 weeks since prior and no concurrent thrombolytic agents

- Anticoagulation therapy with warfarin or low molecular weight heparin is allowed
provided the following criteria are met:

- At least 2 weeks at a stable dose

- INR 2-3

- No active bleeding or pathologic condition that confers a high risk of
bleeding (e.g., tumor involving major vessels or known varices)

- No recent or concurrent participation in another study of experimental drugs
We found this trial at
201
sites
2475 Broadway St
Helena, Montana 59601
(406) 442-2480
St. Peter's Hospital Welcome to St. Peter’s Hospital, providing premier health care to a five–county...
489
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Helena, MT
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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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931 S. 9th Street
Bismarck, North Dakota 58504
701-530-6954
1010
mi
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Bismarck, ND
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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...
1020
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Denver, CO
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
1884
mi
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Flint, MI
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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
mi
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Green Bay, WI
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
1937
mi
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Grosse Pointe Woods, MI
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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
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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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98-1079 Moanalua Rd
Aiea, Hawaii 96701
(808) 486-6000
Kapiolani Medical Center at Pali Momi Pali Momi Medical Center is a nonprofit hospital located...
2678
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Aiea, HI
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1275
mi
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Alexandria, MN
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Ames, Iowa 50010
1449
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Ames, IA
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
2227
mi
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Anderson, SC
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1901
mi
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Ann Arbor, MI
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
1898
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Ann Arbor, MI
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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...
1028
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Aurora, CO
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Aurora, Illinois 60507
1708
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Aurora, IL
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Bemidji, Minnesota 56601
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Bemidji, MN
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1609
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Bettendorf, IA
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Billings, Montana 59101
667
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Billings, MT
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668
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Billings, MT
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Billings, Montana 59101
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Billings, MT
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Billings, Montana 59107
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Billings, MT
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Billings, Montana 59107
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Billings, MT
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2900 12th Ave N Ste 160W
Billings, Montana 59101
(406) 238-6290
Hematology-Oncology Centers of the Northern Rockies - Billings The physicians and staff of Hematology-Oncology Centers...
663
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Billings, MT
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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...
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Bismarck, ND
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Bismarck, North Dakota 58501
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Bismarck, ND
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Bismarck, North Dakota 58501
1009
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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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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...
998
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Boulder, CO
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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
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Bowling Green, OH
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
553
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Bozeman, MT
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Brainerd, Minnesota 56401
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Brainerd, MN
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Brainerd, Minnesota 56401
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Brainerd, MN
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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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Butte, Montana 59701
477
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Butte, MT
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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...
1662
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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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Carthage, IL
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Cedar Rapids, Iowa 52402
1541
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Cedar Rapids, IA
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701 10th St SE
Cedar Rapids, Iowa 52403
(319) 365-4673
Mercy Regional Cancer Center at Mercy Medical Center Hall-Perrine Cancer Center is a part of...
1544
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Cedar Rapids, IA
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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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Cedar Rapids, IA
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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,...
1519
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Chanute, KS
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2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
(719) 776-5000
Penrose Cancer Center at Penrose Hospital Through a full range of clinical trials, genetic counseling,...
1054
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Colorado Springs, CO
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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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Coon Rapids, MN
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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...
2273
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Danville, PA
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18101 Oakwood Blvd
Dearborn, Michigan 48124
(313) 593-8620
Oakwood Cancer Center at Oakwood Hospital and Medical Center In today's health care environment, a...
1931
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Dearborn, MI
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Denver, Colorado 80218
1021
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Denver, CO
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1026
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Denver, CO
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2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
1024
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Denver, CO
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4567 E 9th Ave
Denver, Colorado 80220
(303) 320-2121
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
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Denver, CO
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Des Moines, Iowa 50307
1463
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Des Moines, IA
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1464
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Des Moines, IA
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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...
1463
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Des Moines, IA
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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...
1463
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Des Moines, IA
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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...
1463
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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,...
1462
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Des Moines, IA
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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...
1462
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Des Moines, IA
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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...
1315
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Dodge City, KS
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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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503 North Maple Street
Effingham, Illinois 62401
1779
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Effingham, IL
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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...
1451
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El Dorado, KS
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
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Englewood, CO
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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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Fargo, North Dakota 58122
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Fargo, ND
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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
mi
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Findlay, OH
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
1884
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Flint, MI
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2315 E Harmony Rd #110
Fort Collins, Colorado 80528
(970) 212-7600
Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
988
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Fort Collins, CO
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Fremont, Ohio 43420
1958
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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...
1389
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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,...
1634
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Galesburg, IL
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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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1646
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Green Bay, WI
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1642
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Green Bay, WI
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1642
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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...
1669
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Havana, IL
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Honolula, Hawaii 96813
2679
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Honolula, HI
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1329 Lusitana St. Ste 307
Honolulu, Hawaii 96813
808.524.6115
OnCare Hawaii, Incorporated - Lusitana OnCare Hawaii is a Certified PROVENGE® Treatment Center. PROVENGE (sipuleucel-T)...
2679
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Honolulu, HI
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1301 Punchbowl Street
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Cancer Institute at Queen's Medical Center The Queen
2679
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Honolulu, HI
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2679
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Honolulu, HI
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Honolulu, Hawaii 96817
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Honolulu, HI
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Honolulu, Hawaii 96817
2679
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Honolulu, HI
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
147
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Honolulu, HI
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Hopedale, Illinois 61747
1694
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Hopedale, IL
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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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Hutchinson, MN
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Iron Mountain, Michigan 49801
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Iron Mountain, MI
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205 North East Avenue
Jackson, Michigan 49201
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Jackson, MI
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Jacksonville, Florida 32216
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Jacksonville, FL
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1720
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Joliet, IL
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Kalispell, Montana 59901
373
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Kalispell, MT
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75 Claremont St Ste E
Kalispell, Montana 59901
(406) 752-7600
Glacier Oncology, PLLC Glacier Oncology are physician clinics focusing exclusively on the medical subspecialties of...
373
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Kalispell, MT
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310 Sunnyview Ln
Kalispell, Montana 59901
(406) 752-5111
Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
373
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Kalispell, MT
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Kenton, Ohio 43326
1958
mi
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Kenton, OH
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Kewanee, Illinois 61443
1646
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Kewanee, IL
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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,...
1404
mi
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Kingman, KS
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La Crosse, Wisconsin 54601
1512
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La Crosse, WI
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1923
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Lambertville, MI
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