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S1202: Duloxetine Hydrochloride to Treat Muscle, Bone, and Joint Pain in Pts W/Early-Stage Breast Cancer Receiving Hormone Therapy

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Supportive careActiveNot specifiedNCI, OtherS1202
U10CA037429, NCI-2012-01960, SWOG-S1202, NCT01598298

Trial Description

Summary

RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.

PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.

Further Study Information

OBJECTIVES:

Primary

  • To assess whether daily duloxetine hydrochloride (duloxetine) decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal syndrome (AIMSS), as measured at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF).

Secondary

  • To assess whether daily duloxetine decreases worst joint pain in women with AIMSS, as measured at 12 weeks by the modified BPI-SF.
  • To assess whether daily duloxetine decreases pain interference in women with AIMSS, as measured at 12 weeks by the modified BPI-SF.
  • To investigate whether daily duloxetine improves functioning, pain, and stiffness in the knees/hips according to the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale. (Exploratory)
  • To investigate whether daily duloxetine improves function, pain, and stiffness in the hands according to the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH). (Exploratory)
  • To investigate whether daily duloxetine improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES). (Exploratory)
  • To investigate whether daily duloxetine improves the proportion of patients reporting changes for the better versus worst as measured by the Global Rating of Change Scale. (Exploratory)
  • To investigate whether daily duloxetine decreases analgesic use.
  • To investigate whether daily duloxetine increases adherence to, and reduces the discontinuation rate for, aromatase inhibitor (AI) therapy. (Exploratory)
  • To assess whether patients receiving duloxetine as compared to placebo have improved depression as measured by the Patient Health Questionnaire (PHQ-9) at Weeks 6 and 12. (Exploratory)
  • To explore the relationship between inherited variants in genes responsible for duloxetine metabolism and activity (COMT, HTR3A, SLC6A2, SLC6A4, CYP1A2, CYP2D6) and aromatase (CYP19A1) and change in pain with 12 weeks of treatment. (Exploratory)
  • To explore the impact of treatment on serum inflammatory cytokine levels with 12 weeks of treatment at baseline and 12 weeks. (Exploratory)
  • To bank blood samples for future correlative analyses. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to baseline pain score (4-6 vs 7-10), and prior taxane use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.
  • Arm II: Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.

Patients complete the modified Brief Pain Inventory Short Form (BPI-SF) questionnaire at baseline and periodically during study treatment. Patients may also complete the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale, the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES), Global Rating of Change Scale, and the patient Health Questionnaire (PHQ-9).

Patients undergo blood sample collection at baseline and periodically during treatment for correlative studies, including biomarker and genetic studies.

After completion of study treatment, patients are followed up for 168 days.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Patients must be women with histologically confirmed estrogen receptor (ER)- and/or progesterone receptor (PgR)-positive invasive carcinoma of the breast with no evidence of metastatic disease (M0)
  • Patients must have completed mastectomy or breast-sparing surgery and must have recovered from all side effects of the surgery
  • Patients must have aromatase inhibitor (AI)-associated musculoskeletal symptoms that began or increased after starting AI therapy; new musculoskeletal pain must not be due specifically to fracture or traumatic injury
  • Patients must have completed the S1202 Brief Pain Inventory-Short Form (BPI-SF) within 7 days prior to registration; patients must have an "average pain" of at least 4 on the BPI-SF

PATIENT CHARACTERISTICS:

  • Patients must be post-menopausal, as defined by at least one of the following:
  • At least 12 months since the last menstrual period
  • Prior bilateral oophorectomy
  • Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the post menopausal state; if patient is under the age of 55, FSH levels must be obtained within 28 days prior to registration
  • Patients must have Zubrod performance status of 0-2
  • Patients must have no known allergy or hypersensitivity to duloxetine or any of the inactive ingredients in the matching placebo
  • Patients must not have any contraindicated concurrent illnesses listed on the duloxetine package insert including:
  • Current primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder
  • History of alcohol or other substance abuse or dependence within 365 days prior to registration
  • Chronic liver disease
  • End-stage renal disease
  • Uncontrolled narrow-angle glaucoma
  • Clinically significant coagulation disorder
  • Creatinine clearance > 30 mL/min
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both within 3 x upper limit of normal
  • Total bilirubin within the upper limit of normal
  • Patients must be able to complete study questionnaires in English
  • Patients must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), or cancer involving the bone
  • Patients must be willing to submit blood samples for correlative studies; baseline samples must be obtained prior to beginning protocol treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • If patients were treated with chemotherapy and/or radiation therapy, these treatments must be completed at least 28 days prior to study registration
  • Concurrent bisphosphonate and trastuzumab therapies are allowed
  • Patients should have recovered from all Grade 2 or higher side effects of chemotherapy and/or radiation therapy with the exception of alopecia and peripheral neuropathy
  • Patients must currently be taking one of the following aromatase inhibitor (AI) doses for at least 21 days, but no longer than 12 months, prior to registration and plans to continue for at least an additional 180 days after registration
  • Anastrozole (Arimidex®) 1 mg daily
  • Letrozole (Femara®) 2.5 mg daily
  • Exemestane (Aromasin®) 25 mg daily
  • Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: treatment with phenothiazines, propafenone, flecainide, or linezolid; treatment with monoamine oxidase (MAO)-inhibitor within 14 days prior to registration; or current use of anticoagulation medication (e.g., heparin, warfarin)
  • Patients must not require selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephirine reuptake inhibitors (SNRIs), or tricyclic antidepressants during study participation; patients must have been able to taper and discontinue treatment with these medications at least 7 days prior to registration; patients must not have taken duloxetine or milnacipran within 90 days prior to registration
  • Patients who are receiving treatment with narcotics, tramadol, gabapentin, and/or pregabalin must have been taking a stable dose for at least 30 days prior to registration

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

National Cancer Institute

N. Lynn HenryPrincipal Investigator

Anne F. SchottStudy Chair

Kimberly KaberlePh: 2106148808 Ext.1022
  Email: kkaberle@swog.org

Trial Sites

U.S.A.
Alaska
  Anchorage
 Alaska Breast Care and Surgery LLC
 Kelly S Perlewitz Ph: 503-537-1463
 Anchorage Oncology Centre
 Kelly S Perlewitz Ph: 503-537-1463
 Katmai Oncology Group
 Kelly S Perlewitz Ph: 503-537-1463
 Providence Cancer Center
 Jeanne E. Anderson Ph: 907-261-3109
Arkansas
  Jonesboro
 NEA Medical Clinic - East Matthews
 Carroll Dean Scroggin Ph: 210-614-8808
  Email: protocols@swog.org
California
  Antioch
 Kaiser Permanente - Deer Valley
 Louis Fehrenbacher Ph: 626-564-3455
  Castro Valley
 East Bay Radiation Oncology Center
 James H. Feusner Ph: 510-450-7600
  Fremont
 Kaiser Permanente - Fremont
 Louis Fehrenbacher Ph: 626-564-3455
  Fresno
 Kaiser Permanente Fresno Medical Center
 Louis Fehrenbacher Ph: 626-564-3455
  Hayward
 Kaiser Permanente Medical Center - Hayward
 Louis Fehrenbacher Ph: 626-564-3455
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Arash Asher Ph: 310-423-8965
  Martinez
 Contra Costa Regional Medical Center
 James H. Feusner Ph: 510-450-7600
  Modesto
 Kaiser Permanente-Modesto
 Louis Fehrenbacher Ph: 626-564-3455
  Mountain View
 El Camino Hospital Cancer Center
 James H. Feusner Ph: 510-450-7600
  Oakland
 Alta Bates Summit Medical Center - Summit Campus
 James H. Feusner Ph: 510-450-7600
 Bay Area Breast Surgeons, Incorporated
 James H. Feusner Ph: 510-450-7600
 CCOP - Bay Area Tumor Institute
 James H. Feusner Ph: 510-450-7600
 Epic Care - Oakland
 James H. Feusner Ph: 510-450-7600
 Highland General Hospital
 James H. Feusner Ph: 510-450-7600
 Kaiser Permanente-Oakland
 Louis Fehrenbacher Ph: 626-564-3455
 Larry G Strieff MD Medical Corporation
 James H. Feusner Ph: 510-450-7600
  Pleasanton
 Valley Medical Oncology Consultants - Pleasanton
 James H. Feusner Ph: 510-450-7600
  Redwood City
 Kaiser Permanente Medical Center - Redwood City
 Louis Fehrenbacher Ph: 626-564-3455
  Richmond
 Kaiser Permanente Medical Center - Richmond
 Louis Fehrenbacher Ph: 626-564-3455
  Roseville
 Kaiser Permanente Medical Center - Roseville
 Louis Fehrenbacher Ph: 626-564-3455
  Sacramento
 Kaiser Permanente Medical Center - Sacramento
 Louis Fehrenbacher Ph: 626-564-3455
 South Sacramento Kaiser-Permanente Medical Center
 Louis Fehrenbacher Ph: 626-564-3455
 Sutter Cancer Center
 Nitin Rohatgi Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  San Francisco
 Kaiser Permanente Medical Center - San Francisco Geary Campus
 Louis Fehrenbacher Ph: 626-564-3455
  San Jose
 Kaiser Permanente Medical Center - Santa Teresa
 Louis Fehrenbacher Ph: 626-564-3455
  San Pablo
 Doctors Medical Center - San Pablo Campus
 James H. Feusner Ph: 510-450-7600
  San Rafael
 Kaiser Foundation Hospital - San Rafael
 Louis Fehrenbacher Ph: 626-564-3455
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Louis Fehrenbacher Ph: 626-564-3455
  Santa Rosa
 Kaiser Permanente Medical Center - Santa Rosa
 Louis Fehrenbacher Ph: 626-564-3455
  South San Francisco
 Kaiser Permanente Medical Center - South San Francisco
 Louis Fehrenbacher Ph: 626-564-3455
  Stockton
 Kaiser Permanente Medical Facility - Stockton
 Louis Fehrenbacher Ph: 626-564-3455
  Vacaville
 Kaiser Permanente Medical Center - Vacaville
 Louis Fehrenbacher Ph: 626-564-3455
  Vallejo
 Kaiser Permanente Medical Center - Vallejo
 Louis Fehrenbacher Ph: 626-564-3455
  Walnut Creek
 Kaiser Permanente Medical Center - Walnut Creek
 Louis Fehrenbacher Ph: 626-564-3455
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Tareq Al Baghdadi Ph: 734-712-3456
Florida
  Pensacola
 Sacred Heart Cancer Center at Sacred Heart Hospital
 James F Watkins Ph: 850-416-4611
 Sacred Heart Medical Oncology Group
 James F Watkins Ph: 850-416-4611
Georgia
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 Jennifer Yannucci Ph: 912-350-8568
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
  Honolulu
 Cancer Research Center of Hawaii
 Jeffrey L. Berenberg Ph: 808-586-2979
 Kaiser Permanente - Moanalua Medical Center and Clinic
 Louis Fehrenbacher Ph: 626-564-3455
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey L. Berenberg Ph: 808-586-2979
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
 Straub Clinic and Hospital, Incorporated
 Jeffrey L. Berenberg Ph: 808-586-2979
 Tripler Army Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
  Kailua
 Castle Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
  Lihue
 Kauai Medical Clinic
 Jeffrey L. Berenberg Ph: 808-586-2979
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Tareq Al Baghdadi Ph: 734-712-3456
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith M. Rowland Ph: 800-446-5532
  Berwyn
 MacNeal Cancer Center at MacNeal Hospital
 Mary Beth Leonard Ph: 773-564-5044
  Bloomington
 Illinois CancerCare - Bloomington
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 St. Joseph Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Canton
 Illinois CancerCare - Canton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Carbondale
 Memorial Hospital of Carbondale
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Chicago
 Louis A. Weiss Memorial Hospital
 Keith L. Shulman Ph: 773-564-5044
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Eureka
 Illinois CancerCare - Eureka
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Medical and Surgical Specialists, LLC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Mark F. Kozloff Ph: 708-915-4673
  Email: clinicaltrials@ingalls.org
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Macomb
 Illinois CancerCare - Macomb
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Patricia A Robinson Ph: 708-226-4357
  Monmouth
 Illinois CancerCare - Monmouth
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Normal
 Community Cancer Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Ottawa
 Illinois CancerCare - Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Pekin
 Cancer Treatment Center at Pekin Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Pekin
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peoria
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Methodist Medical Center of Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peru
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Princeton
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  River Forest
 West Suburban Center for Cancer Care
 Isoken Koko Ph: 708-488-0882
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Kendrith M. Rowland Ph: 800-446-5532
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Robin Zon Ph: 574-234-5123
 Elkhart General Hospital
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - Elkhart
 Robin Zon Ph: 574-234-5123
  Indianapolis
 St. Francis Hospital Cancer Care Services
 Howard M. Gross Ph: 765-983-3000
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Robin Zon Ph: 574-234-5123
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Robin Zon Ph: 574-234-5123
  Michigan City
 Saint Anthony Memorial Health Centers
 Kendrith M. Rowland Ph: 800-446-5532
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Robin Zon Ph: 574-234-5123
 Saint Joseph's Medical Center
 Robin Zon Ph: 574-234-5123
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Robin Zon Ph: 574-234-5123
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 765-983-3000
  South Bend
 CCOP - Northern Indiana CR Consortium
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - South Bend
 Robin Zon Ph: 574-234-5123
  Westville
 Michiana Hematology Oncology-PC Westville
 Robin Zon Ph: 574-234-5123
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Arvind Y Vemula Ph: 800-433-3883
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Bruce Wender Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Bruce Wender Ph: 712-252-0088
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker R. Dakhil Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker R. Dakhil Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker R. Dakhil Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker R. Dakhil Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker R. Dakhil Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker R. Dakhil Ph: 316-262-4467
  Manhattan
 Cancer Center of Kansas-Manhattan
 Shaker R. Dakhil Ph: 316-262-4467
  McPherson
 Cancer Center of Kansas, PA - McPherson
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker R. Dakhil Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker R. Dakhil Ph: 316-262-4467
  Topeka
 Cotton-O'Neil Cancer Center
 Mehmood H Hashmi Ph: 785-270-4963
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Associates in Women's Health, PA - North Hillside
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 CCOP - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Kentucky
  Corbin
 Baptist Regional Medical Center
 Arvinda Padmanabhan Ph: 859-260-6425
  Lexington
 Central Baptist Hospital
 Arvinda Padmanabhan Ph: 859-260-6425
Louisiana
  Monroe
 Louisiana State University Health Sciences Center - Monroe
 Gary V Burton Ph: 318-813-1412
  Shreveport
 Christus Schumpert Cancer Treatment Center
 Neelima Chintapalli Ph: 318-681-4763
 Feist-Weiller Cancer Center at Louisiana State University Health Sciences
 Gary V Burton Ph: 318-813-1412
Maine
  Augusta
 Harold Alfond Center for Cancer Care
 Thomas Henry Openshaw Ph: 207-973-4274
  Bangor
 CancerCare of Maine at Eastern Maine Medical Center
 Thomas Henry Openshaw Ph: 207-973-4274
  Rockport
 Penobscot Bay Medical Center Cancer Care Center
 Thomas Henry Openshaw Ph: 207-973-4274
Massachusetts
  Brighton
 Caritas St. Elizabeth's Medical Center
 Dorcas D Chi Ph: 617-789-2903
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Tareq Al Baghdadi Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Tareq Al Baghdadi Ph: 734-712-3456
 University of Michigan Comprehensive Cancer Center
 Norah L Henry Ph: 800-865-1125
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Gilbert D Padula Ph: 616-685-5225
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Tareq Al Baghdadi Ph: 734-712-3456
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Tareq Al Baghdadi Ph: 734-712-3456
 Wayne State University
 Sayeh M Lavasani Ph: 313-576-9363
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Matthew L Ryan Ph: 800-432-6049
  Flint
 Genesys Hurley Cancer Institute
 Tareq Al Baghdadi Ph: 734-712-3456
 Hurley Medical Center
 Tareq Al Baghdadi Ph: 734-712-3456
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 CCOP - Grand Rapids
 Gilbert D Padula Ph: 616-685-5225
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Matthew L Ryan Ph: 800-432-6049
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Tareq Al Baghdadi Ph: 734-712-3456
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Tareq Al Baghdadi Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Tareq Al Baghdadi Ph: 734-712-3456
  Monroe
 Community Cancer Center of Monroe
 Rex B Mowat Ph: 517-265-0116
 Mercy Memorial Hospital - Monroe
 Rex B Mowat Ph: 517-265-0116
  Muskegon
 Mercy General Health Partners
 Gilbert D Padula Ph: 616-685-5225
  Pontiac
 St. Joseph Mercy Oakland
 Tareq Al Baghdadi Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Tareq Al Baghdadi Ph: 734-712-3456
  Reed City
 Spectrum Health Reed City Hospital
 Gilbert D Padula Ph: 616-685-5225
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Tareq Al Baghdadi Ph: 734-712-3456
  Southfield
 Providence Hospital - Southfield
 Andrew A Muskovitz Ph: 248-849-5337
  Email: jaswinder.grewal@stjohn.org
  Traverse City
 Munson Medical Center
 Gilbert D Padula Ph: 616-685-5225
  Warren
 St. John Macomb Hospital
 Tareq Al Baghdadi Ph: 734-712-3456
Minnesota
  Duluth
 CCOP - Duluth
 Bret E Friday Ph: 888-203-7267
 Essentia Health - Duluth Clinic
 Bret E Friday Ph: 888-203-7267
 Miller - Dwan Medical Center
 Bret E Friday Ph: 888-203-7267
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Barbara S Craft Ph: 601-815-6700
Missouri
  Cape Girardeau
 Southeast Cancer Center
 Bryan A Faller Ph: 800-392-0936
  Jefferson City
 Goldschmidt Cancer Center
 Bryan A Faller Ph: 800-392-0936
  Saint Louis
 Missouri Baptist Cancer Center
 Bryan A Faller Ph: 800-392-0936
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
  Helena
 St. Peter's Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Kearney
 Good Samaritan Cancer Center at Good Samaritan Hospital
 George K. Bascom Ph: 308-865-7963
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini S. Soori Ph: 800-253-4368
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Gamini S. Soori Ph: 800-253-4368
 CCOP - Missouri Valley Cancer Consortium
 Gamini S. Soori Ph: 800-253-4368
 Creighton University Medical Center
 Gamini S. Soori Ph: 800-253-4368
 Immanuel Medical Center
 Gamini S. Soori Ph: 800-253-4368
 Lakeside Hospital
 Gamini S. Soori Ph: 800-253-4368
New Jersey
  Vineland
 Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare
 Tami L Bach Ph: 856-641-7933
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Melanie E. Royce Ph: 505-727-8000
New York
  Elmira
 Falck Cancer Center at Arnot Ogden Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
  Rochester
 Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester
 Jonathan W Friedberg Ph: 585-275-5830
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
  White Plains
 Dickstein Cancer Treatment Center at White Plains Hospital Center
 Karen B Green Ph: 914-681-2290
North Carolina
  Asheville
 Mission Hospitals - Memorial Campus
 Christopher H Chay Ph: 828-213-4150
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Hendersonville
 Comprehensive Cancer Center at Pardee Hospital
 James E. Radford Ph: 828-696-4716
 Park Ridge Hospital Breast Health Center
 James Dewitt Bearden Ph: 800-486-5941
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
  Pinehurst
 FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
 Charles S Kuzma Ph: 910-715-2200
  Statesville
 Iredell Memorial Hospital
 Ruby A. Grimm Ph: 704-873-5661
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Esther H. Rehmus Ph: 330-344-6348
 Summa Center for Cancer Care at Akron City Hospital
 Jennifer E Payne Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 Jennifer E Payne Ph: 330-375-6101
  Belpre
 Strecker Cancer Center-Belpre
 J. Philip Kuebler Ph: 614-566-3275
  Bowling Green
 Wood County Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Columbus
 CCOP - Columbus
 J. Philip Kuebler Ph: 614-566-3275
 Columbus Oncology Associates, Incorporated
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 614-566-3275
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Dayton
 CCOP - Dayton
 Howard M. Gross Ph: 765-983-3000
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 765-983-3000
 Good Samaritan Hospital
 Howard M. Gross Ph: 765-983-3000
 Grandview Hospital
 Howard M. Gross Ph: 765-983-3000
  Delaware
 Delaware Health Center
 J. Philip Kuebler Ph: 614-566-3275
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 765-983-3000
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 765-983-3000
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 765-983-3000
  Kettering
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 765-983-3000
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Lima
 Lima Memorial Hospital
 Rex B Mowat Ph: 517-265-0116
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Medina
 Summa Health Center at Lake Medina
 Jennifer E Payne Ph: 330-375-6101
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic - Oregon
 Rex B Mowat Ph: 517-265-0116
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 614-566-3275
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Tiffin
 Mercy Hospital of Tiffin
 Rex B Mowat Ph: 517-265-0116
  Toledo
 CCOP - Toledo Community Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Vincent Mercy Medical Center
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
 Toledo Hospital
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 765-983-3000
  Wauseon
 Fulton County Health Center
 Rex B Mowat Ph: 517-265-0116
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Kelly S Perlewitz Ph: 503-537-1463
  Corvallis
 Good Samaritan Hospital
 David M Hufnagel Ph: 210-616-5798
  Milwaukie
 Providence Milwaukie Hospital
 Kelly S Perlewitz Ph: 503-537-1463
  Newberg
 Providence Newberg Medical Center
 Kelly S Perlewitz Ph: 503-537-1463
  Oregon City
 Willamette Falls Hospital
 Kelly S Perlewitz Ph: 503-537-1463
  Portland
 CCOP - Columbia River Oncology Program
 Kelly S Perlewitz Ph: 503-537-1463
 Providence Cancer Center at Providence Portland Medical Center
 Kelly S Perlewitz Ph: 503-537-1463
 Providence St. Vincent Medical Center
 Kelly S Perlewitz Ph: 503-537-1463
Pennsylvania
  Phoenixville
 Cancer Center at Phoenixville Hospital
 Carl W. Sharer Ph: 610-983-1908
  Williamsport
 Susquehanna Cancer Center at Divine Providence Hospital
 Warren L Robinson Ph: 800-598-4282
South Carolina
  Anderson
 AnMed Cancer Center
 James Dewitt Bearden Ph: 800-486-5941
  Beaufort
 Keyserling Cancer Center at Beaufort Memorial Hospital
 Majd Chahin Ph: 843-522-7819
  Greenville
 Bon Secours St. Francis Health System
 James Dewitt Bearden Ph: 800-486-5941
 Cancer Centers of the Carolinas - Faris Road
 Jeffrey Kent Giguere Ph: 864-241-6251
 Cancer Centers of the Carolinas - Grove Commons
 Jeffrey Kent Giguere Ph: 864-241-6251
 CCOP - Greenville
 Jeffrey Kent Giguere Ph: 864-241-6251
 Greenville Memorial Hospital
 Jeffrey Kent Giguere Ph: 864-241-6251
  Greenwood
 Self Regional Cancer Center at Self Regional Medical Center
 Joanna K Metzner-Sadurski Ph: 864-725-4771
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 Jeffrey Kent Giguere Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey Kent Giguere Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey Kent Giguere Ph: 864-241-6251
 CCOP - Upstate Carolina
 James Dewitt Bearden Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 James Dewitt Bearden Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Mark T Schroeder Ph: 605-716-3982
  Email: research@rcrh.org
Texas
  Laredo
 Doctor's Hospital of Laredo
 Gary W. Unzeitig Ph: 888-823-5923
  Email: ctsucontact@westat.com
Virginia
  Fairfax
 Medical Oncology and Hematology Associates of North Virginia - Fairfax
 Mary J Wilkinson Ph: 703-720-5210ext1044
  Fredericksburg
 Fredericksburg Oncology Inc
 Rex B Mowat Ph: 517-265-0116
  Midlothian
 Bon Secours Cancer Institute - Virginia Breast Center
 William J Irvin Ph: 804-594-4900
  Richmond
 Bon Secours Cancer Institute at St. Mary's Hospital
 William J Irvin Ph: 804-594-4900
Washington
  Vancouver
 Northwest Cancer Specialists at Vancouver Cancer Center
 Kelly S Perlewitz Ph: 503-537-1463
 Southwest Washington Medical Center Cancer Center
 Kelly S Perlewitz Ph: 503-537-1463
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Matthew L Ryan Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Matthew L Ryan Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Matthew L Ryan Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Matthew L Ryan Ph: 800-432-6049
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Matthew L Ryan Ph: 800-432-6049
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Matthew L Ryan Ph: 800-432-6049
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Matthew L Ryan Ph: 800-432-6049
  Sheboygan
 Saint Nicholas Hospital
 Matthew L Ryan Ph: 800-432-6049
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Matthew L Ryan Ph: 800-432-6049
Wyoming
  Casper
 Rocky Mountain Oncology
 Benjamin Thomas Marchello Ph: 800-648-6274
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01598298
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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