Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/10/2018
Start Date:June 2010
End Date:November 1, 2014

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Phase II Trial of Brostallicin and Cisplatin in Patients With Metastatic Triple Negative Breast Cancer

This phase II trial studies how well brostallicin and cisplatin work in treating patients
with breast cancer that has spread to other parts of the body (metastatic) and does not have
estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor
receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as
brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either
by killing the cells or by stopping them from spreading.

PRIMARY OBJECTIVES:

I. To identify any clinical efficacy of brostallicin and cisplatin in the treatment of breast
cancer patients having a triple negative (estrogen receptor [ER]/progesterone receptor
[PR]/HER2 negative) phenotype, as measured by progression-free survival (PFS) at 3 months.

SECONDARY OBJECTIVES:

I. To describe the confirmed tumor response rate of patients with measurable disease
receiving brostallicin and cisplatin.

II. To describe the duration of response in patients with measurable disease receiving
brostallicin and cisplatin.

III. To describe the 6-month progression-free survival of patients receiving brostallicin and
cisplatin.

IV. To describe the overall survival (OS) of patients receiving brostallicin and cisplatin.

V. To evaluate the adverse event profile of the study regimen (adverse events graded using
the Cancer Therapy Evaluation Program [CTEP] Active Version of the Common Terminology
Criteria for Adverse Events [CTCAE]).

OUTLINE:

Patients receive cisplatin intravenously (IV) over 2 hours on day 1 and brostallicin IV over
10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months until disease
progression and then every 6 months for up to 5 years.

Inclusion Criteria

- Histologically or cytologically confirmed adenocarcinoma of the breast with clinical
evidence of metastatic disease

- Triple negative breast cancer defined as HER2-(according to current American Society
of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines), ER-
(defined as =< 1% by IHC) and PgR- (defined as =< 1% by IHC)

- 0 to 4 prior chemotherapy regimens in the metastatic setting

- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
criteria

- Negative pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only

- Hemoglobin >= 10.0 g/dL

- Absolute neutrophil count (ANC) >= 1500/mm^3

- Platelet count >= 100,000/mL

- Total bilirubin =< 1.5 x upper limit of normal (ULN)

- Serum creatinine =< 1.5 mg/dL

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x
ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN if elevations are due to liver metastases

- Alkaline phosphatase =< 2.5 x ULN or alkaline phosphatase =< 5 x ULN if elevations are
due to liver metastases

- Electrocardiogram (EKG) completed =< 15 days prior to registration

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2

- Life expectancy > 3 months

- Has written informed consent

- Willingness to return to NCCTG enrolling institution for treatment and follow-up

- Patient willing to provide blood samples for research purposes

Exclusion Criteria

- HER2 positive (3+ by IHC or fluorescence in situ hybridization [FISH] amplified)
breast cancer by ASCO/CAP guidelines

- Estrogen receptor (ER) and/or progesterone receptor (PR/PgR) positive breast cancer
(defined as > 1% of either receptor by IHC)

- Any of the following

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception (as determined by the treating physician) while on this study and
for 30 days after end of treatment with the study drugs

- Stage III or IV invasive non-breast malignancy in =< 5 years prior to registration

- Pre-existing peripheral neuropathy of grade >= 2 (using the CTEP active version of the
CTCAE)

- Major surgery =< 4 weeks prior to registration

- Chemotherapy or immunologic therapy =< 3 weeks prior to registration

- Radiotherapy =< 2 weeks prior to registration, except if to a non-target lesion only

* NOTES:

- Prior radiation to a target lesion is permitted only if there has been clear
progression of the lesion since radiation was completed

- If patient receives single dose radiation for palliation or radiation to
non-target lesion, they may immediately proceed to registration without waiting 2
weeks

- Acute adverse events from radiation must have resolved to =< grade 1 (according
to the CTEP active version of the CTCAE)

- Evidence of active brain metastasis including leptomeningeal involvement

* NOTE: Central nervous system (CNS) metastasis controlled by prior surgery and/or
radiotherapy is allowed; to be considered controlled, there must be at least 2 months
of no symptoms or evidence of progression prior to study entry and corticosteroid
therapy given to control brain edema must have been discontinued

- History of allergy or hypersensitivity to the drugs used in this study (or their
excipients) including platinum compounds (cisplatin, carboplatin)

- Active, unresolved infection

- Uncontrolled intercurrent illness including, but not limited to psychiatric
illness/social situations or co-morbid systemic illnesses or other severe concurrent
disease which, in the judgment of the investigator, would make the patient
inappropriate for entry into this study or would interfere significantly with the
proper assessment of safety of the prescribed regimens or would limit compliance with
study requirements or would make it undesirable for patient to participate in the
trial

- Clinically significant cardiovascular or cerebrovascular disease, including any
history of the following =< 6 months prior to registration:

- Myocardial infarction

- Unstable angina

- New York Heart Association (NYHA) class II or greater congestive heart failure

- Uncontrolled or clinically significant cardiac arrhythmia (patients with
controlled atrial fibrillation are eligible)

- Currently receiving treatment in a different clinical study in which investigational
procedures are performed or investigational therapies are administered

* NOTE: Patient may not enroll in such clinical trials while participating in this
study; exception may be granted for trials related to symptom management (cancer
control) which do not employ hormonal treatments or treatments that may block the path
of the targeted agents used in this trial

- Immunocompromised patients (other than that related to the use of corticosteroids)
including patients known to be human immunodeficiency virus (HIV) positive with an
acquired immune deficiency syndrome (AIDS)-defining illness; HIV positive patients
with cluster of differentiation (CD)4 count within institutional normal range and no
history of an AIDS-defining illness are eligible
We found this trial at
266
sites
1740 E Broad St
Hazleton, Pennsylvania 18201
(570) 459-2901
Geisinger Hazleton Cancer Center At the Geisinger Cancer Institute, we strive to better understand cancer...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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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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Columbus, OH
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100 North Academy Ave
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
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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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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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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...
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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...
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701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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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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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...
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
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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
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-4673
Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
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Ann Arbor, Michigan 48106
1.877.590.5995
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(303) 363-7200
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Aurora, Illinois 60507
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300 North Ave
Battle Creek, Michigan 49017
(269) 245-8000
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(317) 528-5000
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Billings, Montana 59101
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Billings, Montana 59107
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2900 12th Ave N Ste 160W
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(406) 238-6290
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St. Alexius Medical Center Cancer Center Throughout the healing continuum we are dedicated to our...
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
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2200 E Washington St,
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(309) 662-3311
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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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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,...
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931 Highland Blvd
Bozeman, Montana 59715
(406) 585-5070
Bozeman Deaconess Cancer Center Bozeman Deaconess Cancer Center provides the latest cancer technologies and treatment...
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
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400 S Clark St
Butte, Montana 59701
(406) 723-2616
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210 W Walnut St
Canton, Illinois 61520
(309) 647-5240
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210 W Walnut St
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Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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701 10th St SE
Cedar Rapids, Iowa 52403
(319) 365-4673
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525 10th St SE
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(319) 363-8303
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
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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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12961 27th Ave
Chippewa Falls, Wisconsin 54729
715-738-3700
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12495 University Ave
Clive, Iowa 50325
(515) 358-9700
Mercy Cancer Center - West Lakes When it comes to cancer care, there
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2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
(719) 776-5000
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111 S Grant Avenue
Columbus, Ohio 43215
(614) 566-4321
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Columbus, Ohio 43228
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
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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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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...
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Dayton, Ohio 45406
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1 Wyoming St
Dayton, Ohio 45409
(937) 208-2300
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Dayton, Ohio 45420
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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...
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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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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...
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561 W. Central Avenue
Delaware, Ohio 43015
(740) 615-1000
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11600 W 2nd Pl
Denver, Colorado 80204
(720) 321-0000
St. Anthony Central Hospital The St. Anthony Medical Campus in Lakewood combines our heritage of...
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Denver, Colorado 80218
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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...
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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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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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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
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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
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
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700 West Central
El Dorado, Kansas 67042
(316) 889-0099
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41201 Schadden Rd
Elyria, Ohio 44035
(440) 324-0480
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Elyria, Ohio 44035
(561) 495-8307
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
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Escanaba, Michigan 49431
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101 S Major St
Eureka, Illinois 61530
(309) 467-2371
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101 S Major St
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309-467-2371
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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...
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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...
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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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...
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(620) 223-8589
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105 Mcknight Drive
Franklin, Ohio 45005
513-424-2111
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Fredericksburg, Virginia 22401
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550 Osborne Road
Fridley, Minnesota 55432
763-236-5000
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3315 N. Seminary Street
Galesburg, Illinois 61401
(309) 344-1000
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309-344-9269
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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,...
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mi
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Grand Forks, ND
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2635 North 7th Street
Grand Junction, Colorado 81501
970-298-CARE (2273)
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center St. Mary's Hospital...
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Grand Junction, CO
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Grand Rapids, Michigan 49503
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Grand Rapids, MI
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250 Cherry St SE
Grand Rapids, Michigan 49503
(616) 685-5225
Lacks Cancer Center at Saint Mary's Health Care Mercy Health Lacks Cancer Center was one...
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mi
from
Grand Rapids, MI
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