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Chemotherapy Toxicity On Quality of Life in Older Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/EpidemiologyActive70 and overNCI, OtherGOG-0273
NCI-2011-02900, U10CA101165, NCT01366183

Trial Description

Summary

This trial studies the chemotherapy toxicity on quality of life in older patients with stage I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.

Further Study Information

PRIMARY OBJECTIVES:

l. To determine whether the score on Instrumental Activities of Daily Living (IADL) obtained prior to treatment is associated with the ability of patients to complete four cycles of chemotherapy without dose reduction or a more than 7-day delay.

II. To estimate by regimen the percentage of patients who are able to complete four cycles of chemotherapy regardless of dose reductions and delays.

III. To compare actual and calculated carboplatin area under the curve (AUC) in this patient population.

SECONDARY OBJECTIVES:

I. To describe the percentage of patients who are entered after primary surgery versus those entered to receive primary or neoadjuvant chemotherapy, the percentage of patients who are treated with each allowed regimen, and the percentage of patients who eventually receive surgery in the primary chemotherapy group.

II. To determine whether the need for assistance with IADLs at time of registration is associated with choice of chemotherapy regimen (in both primary chemotherapy and primary surgery patients).

III. To explore whether age, baseline scores on the geriatric measures (functional status, nutritional status, or co-morbidity) and quality-of-life (QOL) are correlated with likelihood of completing four courses of chemotherapy without dose reduction or a more than 7-day delay.

IV. To explore reasons for and timing of dose reductions and delays. V. To describe toxicities, pre-/post-chemotherapy QOL, and pre-/post-chemotherapy scores on geriatric measures in this patient population.

TERTIARY OBJECTIVES:

I. To explore potential relationships of carboplatin AUC, paclitaxel clearance, and paclitaxel time above a plasma concentration of 0.05 mcM to nadir neutrophil and platelet counts during course 1 of treatment.

II. To explore the association between baseline IADL and survival. III. To explore the association between IADL and the functional well-being (FWB) subscale in the Functional Assessment of Cancer Therapy - Ovary (FACT-O).

OUTLINE:

Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim (regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy at the discretion of treating physician. Patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies.

Patients' quality of life is assessed by the FACT-O, the Functional Assessment of Cancer Treatment - Neurotoxicity (FACT-Ntx subscale), the IADL, and the Ability to Complete Social Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after completion of course 4. Nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment are also assessed.

Eligibility Criteria

Inclusion Criteria:

  • Eligible patients must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the ovary, peritoneum, or fallopian tube either by surgery, biopsy, fine-needle aspiration (FNA), paracentesis, or thoracentesis; a diagnosis of a mucinous cancer must be made by biopsy only
  • International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, and IV are eligible
  • Patients must have received no previous treatment for this malignancy other than surgery
  • Patients must be entered within eight weeks of confirmation of disease diagnosis by surgery, biopsy, FNA, paracentesis or thoracentesis if there is no primary surgery, and within twelve weeks of primary or staging surgery if patient received primary surgery
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Bilirubin less than or equal upper limit of normal (ULN)
  • Creatinine less than or equal to 1.5 x ULN
  • Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, 2 or 3
  • Effective XX/XX/2014, only patients 75 years of age or older are eligible for enrollment; (04/23/2012) (08/12/2013)
  • Patients must have recovered from the effects of recent surgery
  • Patients must be free of active infection requiring antibiotics
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA)
  • Patient and physician agree that they plan to conduct treatment according to Regimen 3
  • Patient can read and understand sufficient English to be able to respond to questions posed by the study instruments

Exclusion Criteria:

  • Patients who have received previous treatment for this malignancy other than surgery
  • Patients with other invasive malignancies whose previous cancer treatment contraindicates this protocol therapy
  • "Borderline tumors" (tumors of low malignant potential) by surgery or biopsy are excluded
  • Patients with medical conditions that in the opinion of the investigator render treatment on this protocol unsafe should be excluded

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Vivian von GruenigenPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Larry C Kilgore Ph: 865-544-9773
Arizona
  Phoenix
 GOG of Arizona, PC
 Vivian von Gruenigen Ph: 330-379-3514
  Email: vongruev@summahealth.org
 St. Joseph's Hospital and Medical Center
 John H Farley Ph: 602-406-6689
  Scottsdale
 Mayo Clinic Scottsdale
 Jamie N Bakkum-Gamez Ph: 507-538-7623
  Tucson
 Arizona Cancer Center at University Medical Center North
 Setsuko K Chambers Ph: 520-626-9008
California
  LA Jolla
 Rebecca and John Moores UCSD Cancer Center
 Michael T. McHale Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  Mountain View
 Palo Alto Medical Foundation
 Albert L Pisani Ph: 650-934-7000
  Orange
 Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
 Krishnansu S Tewari Ph: 714-456-6191
  Email: awallick@uci.edu
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 John K Chan Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
  Stanford
 Stanford Cancer Center
 Jonathan S. Berek Ph: 650-498-7061
  Email: clinicaltrials@med.stanford.edu
  Sylmar
 Olive View - UCLA Medical Center Foundation
 Christine Holschneider Ph: 888-798-0719
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 James S. Hoffman Ph: 860-224-5660
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Middletown
 Middlesex Hospital Cancer Center
 Susanna Hong Ph: 860-358-2058
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 James S. Hoffman Ph: 860-224-5660
  New Haven
 Yale Cancer Center
 Thomas J Rutherford Ph: 203-785-5702
  Stamford
 Carl and Dorothy Bennett Cancer Center at Stamford Hospital
 Salvatore A. Del Prete Ph: 203-323-8944
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Mark E Borowsky Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Mark E Borowsky Ph: 302-733-6227
Florida
  Fort Lauderdale
 Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Fort Myers
 Florida Gynecologic Oncology - Fort Myers
 Edward C. Grendys Ph: 800-874-7502
  Jupiter
 Ella Milbank Foshay Cancer Center at Jupiter Medical Center
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Sarasota
 Sarasota Memorial Hospital
 James V. Fiorica Ph: 941-917-2225
  Tampa
 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
 Robert M Wenham Ph: 800-456-7121
  Email: canceranswers@moffitt.org
Georgia
  Augusta
 Medical College of Georgia Cancer Center
 Sharad Anant Ghamande Ph: 706-721-1663
  Email: cancer@georgiahealth.edu
  Columbus
 John B. Amos Cancer Center
 Gregory P Sfakianos Ph: 706-660-6404
  Decatur
 Charles B. Eberhart Cancer Center at DeKalb Medical Center
 Jayanthi Srinivasiah Ph: 404-501-3279
  Gainesville
 Northeast Georgia Medical Center
 Andrew E Green Ph: 770-219-8800
  Email: cancerpatient.navigator@nghs.com
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 James J Burke Ph: 912-350-8568
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 William Edward Richards Ph: 800-622-6877
  Email: uchealthnews@uc.edu
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-3456
Illinois
  Chicago
 Louis A. Weiss Memorial Hospital
 Keith L. Shulman Ph: 773-564-5044
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Julian C. Schink Ph: 616-391-3050
  Email: cancer@northwestern.edu
  Hinsdale
 Gynecologic Oncology
 Sudarshan K. Sharma Ph: 630-856-6757
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
  River Forest
 West Suburban Center for Cancer Care
 Isoken Koko Ph: 708-488-0882
  Warrenville
 Central Dupage Cancer Center
 Barbara M Buttin Ph: 630-352-5300
  Email: cancer@northwestern.edu
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
  Elkhart
 Elkhart Clinic, LLC
 Michael W. Method Ph: 574-237-1328
 Elkhart General Hospital
 Michael W. Method Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - Elkhart
 Michael W. Method Ph: 574-237-1328
  Indianapolis
 St. Vincent Oncology Center
 Gregory P. Sutton Ph: 317-338-2194
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Michael W. Method Ph: 574-237-1328
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Michael W. Method Ph: 574-237-1328
  Mishawaka
 Cancer Care Partners LLC
 Michael W. Method Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - Mishawaka
 Michael W. Method Ph: 574-237-1328
 Saint Joseph's Medical Center
 Michael W. Method Ph: 574-237-1328
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Michael W. Method Ph: 574-237-1328
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 765-983-3000
  South Bend
 CCOP - Northern Indiana CR Consortium
 Michael W. Method Ph: 574-237-1328
 Memorial Hospital of South Bend
 Michael W. Method Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - South Bend
 Michael W. Method Ph: 574-237-1328
 South Bend Clinic
 Michael W. Method Ph: 574-237-1328
  Westville
 Michiana Hematology Oncology-PC Westville
 Michael W. Method Ph: 574-237-1328
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Clive
 Medical Oncology and Hematology Associates-West Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center - West Lakes
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 David P Bender Ph: 800-237-1225
  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
  West Des Moines
 Methodist West Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
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
  Kansas City
 Providence Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  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
  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
  Overland Park
 Menorah Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Saint Luke's Hospital - South
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Prairie Village
 CCOP - Kansas City
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  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
 David E Einspahr 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
  Edgewood
 St. Elizabeth Medical Center
 Jack Basil Ph: 859-301-5473
  Email: darla.hehman@stelizabeth.com
  Lexington
 Central Baptist Hospital
 Hope M Cottrill Ph: 859-260-6425
  Louisville
 Louisville Oncology at Norton Cancer Institute - Louisville
 Mary E Gordinier Ph: 502-629-2500
Louisiana
  Baton Rouge
 Woman's Hospital
 Giles Fort Ph: 225-215-1353
  Email: clinicalreserach@marybird.com
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Richard C. Kline Ph: 888-562-4763
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
  Portland
 Maine Medical Center - Bramhall Campus
 Christopher J Darus Ph: 207-885-7565
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Paul Celano Ph: 443-849-3706
 Greenebaum Cancer Center at University of Maryland Medical Center
 Sarah M Temkin Ph: 800-888-8823
Massachusetts
  Burlington
 Lahey Clinic Medical Center - Burlington
 Corrine L Zarwan Ph: 781-744-8027
  Plymouth
 Jordan Hospital Club Cancer Center
 James M Koomey Ph: 508-830-2390
  Email: cancerinfo@jordanhospital.org
  Worcester
 Levine Cancer Center at UMass Medical Center - Memorial Campus
 Susan L. Zweizig Ph: 508-856-3216
  Email: cancer.research@umassmed.edu
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip J. Stella Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Thomas E Buekers Ph: 313-916-1784
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
 Wayne State University
 Robert T. Morris Ph: 313-576-9363
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Jonathan E Tammela Ph: 920-433-8889
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
 Philip J. Stella Ph: 734-712-3456
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-3456
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Jonathan E Tammela Ph: 920-433-8889
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella 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
 Philip J. Stella Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-3456
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Michael W. Method Ph: 574-237-1328
  Southfield
 Providence Hospital - Southfield
 Vinay Kumar Malviya Ph: 248-849-5337
  Email: jaswinder.grewal@stjohn.org
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Michael W. Method Ph: 574-237-1328
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-3456
Minnesota
  Bemidji
 MeritCare Bemidji
 Maria C. Bell Ph: 218-333-5000
  Minneapolis
 Masonic Cancer Center at University of Minnesota
 Peter A Argenta Ph: 612-624-2620
  Rochester
 Mayo Clinic Cancer Center
 Jamie N Bakkum-Gamez Ph: 507-538-7623
  Saint Louis Park
 Park Nicollet Cancer Center
 Rachel E Lerner Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Rachel E Lerner Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Missouri
  Kansas City
 Heartland Hematology Oncology Associates, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 North Kansas City Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Research Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Lee's Summit
 Saint Luke's East - Lee's Summit
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Liberty
 Parvin Radiation Oncology
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Saint Joseph
 Heartland Regional Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Saint Joseph Oncology, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Gardner Mutch Ph: 800-600-3606
  Email: info@ccadmin.wustl.edu
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
 St. John's Regional Health Center
 Jay W Carlson Ph: 888-244-6061
  Email: sherrijr@iora.org
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
  Omaha
 Methodist Estabrook Cancer Center
 Peter C. Morris Ph: 402-354-7939
  Email: kathryn.bartz@nmhs.org
Nevada
  Las Vegas
 Women's Cancer Center - La Canada
 Nick M. Spirtos Ph: 702-851-4672
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 David P. Warshal Ph: 856-325-6757
  Hackensack
 CCOP - Northern New Jersey
 Donna T McNamara Ph: 201-996-2879
 Hackensack University Medical Center Cancer Center
 Donna T McNamara Ph: 201-996-2879
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Randolph B Deger Ph: 888-847-8823
  Newark
 UMDNJ University Hospital
 Bernadette M. Cracchiolo Ph: 732-235-8675
  Voorhees
 Fox Chase Virtua Health Cancer Program at Virtua West Jersey
 Randolph B Deger Ph: 888-847-8823
New Mexico
  Albuquerque
 Southwest Gynecologic Oncology Associates, Incorporated
 Teresa L Rutledge Ph: 505-272-6972
 University of New Mexico Cancer Center
 Teresa L Rutledge Ph: 505-272-6972
New York
  Albany
 Women's Cancer Care Associates
 Thomas P Morrissey Ph: 518-458-1390
  Buffalo
 Roswell Park Cancer Institute
 Shashikant B. Lele Ph: 877-275-7724
  Glens Falls
 Charles R. Wood Cancer Center at Glens Falls Hospital
 Eric A Pillemer Ph: 518-926-6700
  Lake Success
 Monter Cancer Center of the North Shore-LIJ Health System
 Veena S John Ph: 516-562-3467
  Manhasset
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Veena S John Ph: 516-562-3467
  New Hyde Park
 Long Island Jewish Medical Center
 Veena S John Ph: 516-562-3467
  New York
 Memorial Sloan-Kettering Cancer Center
 William P Tew Ph: 212-639-7202
 New York University Medical Center
 Stephanie V. Blank Ph: 212-263-4434
  Email: prmc.coordinator@nyumc.org
  Stony Brook
 Stony Brook University Cancer Center
 Michael L. Pearl Ph: 800-862-2215
  Syracuse
 SUNY Upstate Medical University Hospital
 Mary J Cunningham Ph: 315-464-5476
North Carolina
  Burlington
 Alamance Cancer Center at Alamance Regional Medical Center
 Janak K. Choksi Ph: 336-538-7725
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Robert Victor Higgins Ph: 704-355-2884
 Presbyterian Cancer Center at Presbyterian Hospital
 John M McDonald Ph: 704-384-5369
  Concord
 Batte Cancer Center at Northeast Medical Center
 Brigitte E. Miller Ph: 704-403-1520
  Durham
 Duke Cancer Institute
 Angeles Alvarez Secord Ph: 888-275-3853
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Raleigh
 Duke Health Raleigh Hospital
 Angeles Alvarez Secord Ph: 888-275-3853
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Samuel S. Lentz Ph: 336-713-6771
North Dakota
  Bismarck
 Bismarck Cancer Center
 John T Reynolds Ph: 701-323-5760
  Email: tfischer@mohs.org
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Maria C. Bell Ph: 218-333-5000
 Sanford Clinic North-Fargo
 Maria C. Bell Ph: 218-333-5000
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
 Vivian von Gruenigen Ph: 330-375-6101
  Belpre
 Strecker Cancer Center-Belpre
 J. Philip Kuebler Ph: 614-566-3275
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Cleveland
 Case Comprehensive Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
 Cleveland Clinic Cancer Center at Fairview Hospital
 Steven E. Waggoner Ph: 800-641-2422
 Cleveland Clinic Taussig Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Peter Graham Rose Ph: 866-223-8100
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 David M O'Malley Ph: 866-627-7616
  Email: osu@emergingmed.com
 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
 Jeffrey G. Bell Ph: 614-566-4475
 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
 Samaritan North Cancer Care Center
 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
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Steven E. Waggoner Ph: 800-641-2422
  Mentor
 Lake/University Ireland Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
  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
  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
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 765-983-3000
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Xenia
 Ruth G. McMillan Cancer Center at Greene Memorial Hospital
 Howard M. Gross Ph: 765-983-3000
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Tulsa
 Cancer Care Associates-Yale
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
 Natalie Warren Bryant Cancer Center at St. Francis Hospital
 David G. McIntosh Ph: 601-815-6700
Pennsylvania
  Bethlehem
 St. Luke's Cancer Network at St. Luke's Hospital
 Nicholas P Taylor Ph: 610-954-3582
  Email: infolink@slhn.org
  Gettysburg
 Adams Cancer Center
 Timothy B. McGuinness Ph: 877-441-7957
  Hanover
 Cherry Tree Cancer Center
 Timothy B. McGuinness Ph: 877-441-7957
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Stephanie A. King Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Allison Zibelli Ph: 215-955-6084
 Temple Cancer Center at Temple University Hospital
 Enrique Hernandez Ph: 215-728-2983
  Pittsburgh
 UPMC Cancer Centers
 Robert P. Edwards Ph: 412-647-2811
  West Chester
 Cancer Center of Chester County
 William E. Luginbuhl Ph: 610-431-5297
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Bernice L Robinson-Bennett Ph: 610-988-9323
  York
 WellSpan Health
 Timothy B. McGuinness Ph: 877-441-7957
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Paul A. DiSilvestro Ph: 401-274-1122
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Luis A Rojas-Espaillat Ph: 800-657-4377
  Email: Jan.Healy@avera.org
 Sanford Cancer Center at Sanford USD Medical Center
 Maria C. Bell Ph: 218-333-5000
 Maria C. Bell Ph: 218-333-5000
Texas
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Jubilee Brown Ph: 713-792-3245
  Email: jbbrown@mdanderson.org
Vermont
  Burlington
 Fletcher Allen Health Care - Medical Center Campus
 Cheung Wong Ph: 802-656-8990
Virginia
  Roanoke
 Carilion Clinic Gynecological Oncology
 Janet L. Osborne Ph: 540-985-8510
Wisconsin
  Eau Claire
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Anthony C. Evans Ph: 715-389-4457
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Jonathan E Tammela Ph: 920-433-8889
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
 St. Mary's Hospital Medical Center - Green Bay
 Jonathan E Tammela Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 David M Kushner Ph: 877-405-6866
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Jonathan E Tammela Ph: 920-433-8889
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Jonathan E Tammela Ph: 920-433-8889
  Marshfield
 Marshfield Clinic - Marshfield Center
 Anthony C. Evans Ph: 715-389-4457
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 William H Bradley Ph: 414-805-4380
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Scott A Kamelle Ph: 414-649-7200
  Minocqua
 Marshfield Clinic - Lakeland Center
 Anthony C. Evans Ph: 715-389-4457
  Mukwonago
 D.N. Greenwald Center
 Janet Drake Ph: 262-928-7632
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Janet Drake Ph: 262-928-7632
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Jonathan E Tammela Ph: 920-433-8889
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Zahid N Dar Ph: 800-252-2990
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Anthony C. Evans Ph: 715-389-4457
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Anthony C. Evans Ph: 715-389-4457
  Sheboygan
 Vince Lombardi Cancer Clinic - Sheboygan
 Santhosh Kumar Ph: 414-649-7200
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Anthony C. Evans Ph: 715-389-4457
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Jonathan E Tammela Ph: 920-433-8889
  Summit
 Aurora Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Janet Drake Ph: 262-928-7632
  Wausau
 Marshfield Clinic - Wausau Center
 Anthony C. Evans Ph: 715-389-4457
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Peter Johnson Ph: 800-252-2990
  Weston
 Marshfield Clinic - Weston Center
 Anthony C. Evans Ph: 715-389-4457
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Anthony C. Evans Ph: 715-389-4457
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 NCT01366183
ClinicalTrials.gov processed this data on March 25, 2014

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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