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Clinical Trials (PDQ®)

Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCI, OtherGOG-0277
NCI-2012-00249, CDR0000724874, IRCI 001, U10CA027469, NCT01533207

Trial Description

Summary

This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine whether overall survival of patients with uterus-limited high-grade leiomyosarcoma is superior among patients assigned to treatment with adjuvant gemcitabine hydrochloride plus docetaxel followed by doxorubicin hydrochloride compared to patients assigned to observation.

SECONDARY OBJECTIVES:

I. To determine whether treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin improves recurrence-free survival of patients with uterus-limited high-grade leiomyosarcoma compared to observation.

II. To explore the impact of potential predictors of recurrence or death such as patient age, institution-reported tumor size, cervix involvement (yes or no), and mitotic rate. (exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to country of treating site. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive adjuvant gemcitabine hydrochloride IV over 70-90 minutes on days 1 and 8 and docetaxel IV over 30-60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo computed tomography (CT) and/or magnetic resonance imaging (MRI). Patients with no evidence of disease receive doxorubicin hydrochloride IV every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim SC on days 2-8 or pegfilgrastim SC on day 2 or 3.

Arm II: Patients undergo clinical observation.

Patients may undergo tumor tissue sample collection at baseline for future correlative studies.

After completion of study treatment, patients in both arms are followed up every 4 months for 3 years and then every 6 months for 2 years.

Eligibility Criteria

Inclusion Criteria:

  • Patients with high-risk uterine leiomyosarcoma (LMS), International Federation of Gynecology and Obstetrics (FIGO) stage I (confined to corpus +/- cervix); patients with known uterine serosa involvement are not eligible; patients should have had, at least, a complete hysterectomy (including removal of the cervix); bilateral salpingo-oophorectomy (BSO) is not required
  • Institutional pathology review calls the uterine leiomyosarcoma "high grade"
  • Additionally, if the pathology report indicates a mitotic rate, the mitotic rate should be greater than or equal to 5 mitoses/10 high-power field
  • All patients must be no longer than 12 weeks (3 months) from surgical resection of cancer at the time of enrollment on study; if a patient requires a second operation to complete her surgery, i.e., trachelectomy to remove the cervix and/or BSO, the 12 weeks may be counted from the time of the second operation
  • Patients who had a "morcellation" hysterectomy procedure that involved morcellation within the peritoneal cavity are eligible IF a second operation is performed and biopsies from the second procedure show no evidence of leiomyosarcoma
  • All patients must have no evidence of persistent or metastatic disease as documented by a post-resection computed tomography (CT) of the chest/abdomen/pelvis or by CT chest + magnetic resonance imaging (MRI) abdomen/pelvis; the post-resection imaging studies should be performed within 4 weeks of registration on study
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL (ANC >= 1.5 x 10^9/L)
  • Platelets greater than or equal to 100,000/mcL (platelets >= 100 x 10^9/L)
  • Hemoglobin greater than 8.0 g/dL (= 80 g/L or 4.9 mmol/L)
  • Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
  • Bilirubin* within normal range
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])* and serum glutamic pyruvate transaminase(SGPT) (alanine aminotransferase [ALT])* less than or equal to 2.5 times ULN
  • Alkaline phosphatase* less than or equal to 2.5 x ULN
  • * Patients with a history of Gilbert's syndrome may be eligible provided total bilirubin is less than or equal to 1.5 x ULN and the AST, ALT, and alkaline phosphatase meet the criteria detailed
  • Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events(CTCAE) grade 1
  • Patients with Gynecologic Oncology Group (GOG) performance status (PS) of 0 or 1 OR Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 OR Karnofsky PS >= 80%
  • Patients must have signed an approved informed consent
  • Patients participating through U.S. sites must sign an approved and authorization permitting release of personal health information
  • Patients should be free of active infection requiring antibiotics (with the exception of an uncomplicated urinary tract infection [UTI])

Exclusion Criteria:

  • Patients who have had prior therapy with docetaxel, gemcitabine hydrochloride, or doxorubicin hydrochloride at any time in their history
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are ineligible if there is any evidence of other malignancy being present within the last five years
  • Patients are ineligible if their previous cancer treatment contraindicates this protocol therapy
  • Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel) or other drugs formulated with polysorbate 80
  • Patients with GOG performance status of 2, 3 or 4; or ECOG performance status of 2, 3 or 4
  • Patients who are breast-feeding
  • Patients with a known history of congestive heart failure or cardiac ejection fraction < 50% (or less than institutional normal limits); echocardiogram (ECHO) or multigated acquisition scan (MUGA) is not required prior to enrollment; for patients assigned to the chemotherapy arm, an ECHO or MUGA should be done within 6 months of day 1 of gemcitabine-docetaxel treatment
  • Patients who enroll on study and are randomized to Regimen I (chemotherapy ) and then are found on baseline ECHO or MUGA to have cardiac ejection fraction < 50% or below institutional normal will remain ON study; such patients will receive gemcitabine + docetaxel for 4 cycles but will NOT receive any doxorubicin treatment; they will continue treatment follow-up as outlined for all patients assigned to Regimen I
  • Patients with a history of whole pelvic radiation
  • Concurrent treatment with hormone replacement therapy is permitted at the discretion of the treating physician; patients who have been taking hormonal/hormone-blocking agents for breast cancer or breast cancer prevention or other indication are eligible; use of anti-hormonal agents (tamoxifen, medroxyprogesterone, aromatase inhibitors) is permitted at the discretion of the treating physician
  • Patients with recurrent uterine LMS
  • Patients who are known to be human immunodeficiency virus (HIV) positive are not eligible
  • Patients with gross residual or metastatic tumor findings following complete surgical treatment for uterine LMS

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Martee HensleyPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Huntsville
 Tennessee Valley Gynecologic Oncology
 David B Engle Ph: 256-533-6233
California
  Auburn
 Auburn Radiation Oncology
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
 Sutter Auburn Faith Hospital
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Berkeley
 Alta Bates Summit Comprehensive Cancer Center
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Burbank
 Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
 Alison K Conlin Ph: 503-215-6412
  Burlingame
 Peninsula Medical Center
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Cameron Park
 Radiation Oncology Centers - Cameron Park
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Davis
 Sutter Davis Hospital
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Michael T. McHale Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  Loma Linda
 Loma Linda University Cancer Institute at Loma Linda University Medical Center
 Yevgeniya J Ioffe Ph: 909-558-4050
  Los Angeles
 Kaiser Permanente Medical Center - Los Angeles
 Scott E. Lentz Ph: 626-564-3455
  Modesto
 Memorial Medical Center
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Mountain View
 Palo Alto Medical Foundation
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
 Albert L Pisani Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Novato
 Sutter Health Western Division Cancer Research Group
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Palo Alto
 Palo Alto Medical Foundation - Palo Alto
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Roseville
 Radiation Oncology Center - Roseville
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
 Sutter Cancer Center at Roseville Medical Center
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Sacramento
 Sutter Cancer Center
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  San Francisco
 California Pacific Medical Center - California Campus
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Santa Cruz
 Palo Alto Medical Foundation-Santa Cruz
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Santa Rosa
 Sutter Pacific Medical Foundation
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Sunnyvale
 Palo Atlo Medical Foundation-Sunnyvale
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Sylmar
 Olive View - UCLA Medical Center Foundation
 Christine Holschneider Ph: 888-798-0719
  Vacaville
 Solano Radiation Oncology Center
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
  Vallejo
 Sutter Solano Medical Center
 John K Chan Ph: 415-209-2686
  Email: bernicl@sutterhealth.org
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Aurora
 Keren Sturtz Ph: 888-785-6789
 University of Colorado Cancer Center at UC Health Sciences Center
 Susan Davidson Ph: 720-848-0650
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Keren Sturtz Ph: 888-785-6789
 Southwest Oncology, PC
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Littleton
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Longmont
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 Rocky Mountain Cancer Centers - Pueblo
 Keren Sturtz Ph: 888-785-6789
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Thornton
 Rocky Mountain Cancer Centers - Thornton
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 James S. Hoffman Ph: 860-224-5660
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 James S. Hoffman Ph: 860-224-5660
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Mark E Borowsky Ph: 302-733-6227
  Newark
 Christiana Gynecologic Oncology, LLC
 Mark E Borowsky Ph: 302-733-6227
 Delaware Clinical and Laboratory Physicians
 Mark E Borowsky Ph: 302-733-6227
 Helen F. Graham Cancer Center at Christiana Hospital
 Mark E Borowsky Ph: 302-733-6227
 Mark E Borowsky Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 Mark E Borowsky Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 Mark E Borowsky Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 Mark E Borowsky Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Mark E Borowsky Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 Mark E Borowsky Ph: 302-733-6227
District of Columbia
  Washington
 Sibley Memorial Hospital
 Mildred Rodriguez Chernofsky Ph: 202-243-2373
Florida
  Altamonte Springs
 Florida Hospital - Altamonte
 James E Kendrick Ph: 407-303-5623
  Kissimmee
 Florida Hospital Kissimmee
 James E Kendrick Ph: 407-303-5623
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 James E Kendrick Ph: 407-303-5623
 Florida Hospital East Orlando
 James E Kendrick Ph: 407-303-5623
 Florida Urology Associates-Orlando
 James E Kendrick Ph: 407-303-5623
  Winter Park
 Florida Hospital Cancer Institute at Winter Park
 James E Kendrick Ph: 407-303-5623
Georgia
  Atlanta
 Northside Hospital Cancer Center
 Gina Z D'Amato Ph: 404-303-3355
 Piedmont Hospital
 John Warren McBroom
  Email: ORS@piedmont.org
  Decatur
 Charles B. Eberhart Cancer Center at DeKalb Medical Center
 Cyril O Spann Ph: 404-501-3279
  Gainesville
 Northeast Georgia Medical Center
 Andrew E Green Ph: 770-219-8800
  Email: cancerpatient.navigator@nghs.com
  Savannah
 Low Country Cancer Care Associates, PC
 Howard A. Zaren Ph: 800-622-6877
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 Howard A. Zaren Ph: 800-622-6877
Hawaii
  Honolulu
 Cancer Research Center of Hawaii
 Michael E. Carney Ph: 808-983-6090
 Kapiolani Medical Center for Women and Children
 Michael E. Carney Ph: 808-983-6090
 MBCCOP - Hawaii
 Michael E. Carney Ph: 808-983-6090
 Queen's Cancer Institute at Queen's Medical Center
 Michael E. Carney Ph: 808-983-6090
 Tripler Army Medical Center
 Charles S Dietrich Ph: 808-433-6336
Idaho
  Lewiston
 St. Joseph Regional Medical Center
 John A Keech Ph: 907-458-5380
  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
  Chicago
 John H. Stroger, Jr. Hospital of Cook County
 Thomas E. Lad Ph: 312-864-6000
 Mount Sinai Hospital Medical Center
 Pam G. Khosla Ph: 773-257-5960
  Email: suhi@sinai.org
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Emily Berry Ph: 312-695-1301
  Email: cancer@northwestern.edu
 Rush Cancer Institute at Rush University Medical Center
 Alfred S Guirguis Ph: 312-942-5498
  Email: clinical_trials@rush.edu
 University of Chicago Cancer Research Center
 Meaghan E Tenney Ph: 773-834-7424
  Danville
 Carle on Vermilion
 Kendrith M. Rowland Ph: 800-446-5532
  Effingham
 Carle Physician Group-Effingham
 Kendrith M. Rowland Ph: 800-446-5532
  Hinsdale
 Gynecologic Oncology
 Sudarshan K. Sharma Ph: 630-856-6757
  Mattoon
 Carle Physician Group-Mattoon/Charleston
 Kendrith M. Rowland Ph: 800-446-5532
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  New Lennox
 Silver Cross Hospital
 Meaghan E Tenney Ph: 773-834-7424
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Kendrith M. Rowland Ph: 800-446-5532
 Kendrith M. Rowland Ph: 800-446-5532
  Yorkville
 Rush-Copley Healthcare Center
 Kendrith M. Rowland Ph: 800-446-5532
Indiana
  Indianapolis
 St. Vincent Oncology Center
 Gregory P. Sutton Ph: 317-338-2194
  Michigan City
 Saint Anthony Memorial Health Centers
 Kendrith M. Rowland Ph: 800-446-5532
 Woodland Cancer Care Center
 Kendrith M. Rowland Ph: 800-446-5532
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 937-775-1350
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
 William R. Bliss Cancer Center at Mary Greeley Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Boone
 McFarland Clinic PC-Boone
 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
  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
  Fort Dodge
 Trinity Regional Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 David P Bender Ph: 800-237-1225
  Jefferson
 McFarland Clinic PC-Jefferson
 Joseph James Merchant Ph: 515-239-2621
  Marshalltown
 McFarland Clinic PC-Marshalltown
 Joseph James Merchant Ph: 515-239-2621
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
  West Des Moines
 Methodist West Hospital
 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
  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
  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
  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
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
 Wesley Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Kentucky
  Crestview Hills
 Oncology Hematology Care, Incorporated - Crestview Hills
 Howard M. Gross Ph: 937-775-1350
Louisiana
  Baton Rouge
 Woman's Hospital
 Giles Fort Ph: 225-215-1353
  Email: clinicalreserach@marybird.com
Maine
  Scarborough
 Maine Medical Center- Scarborough Campus
 Christopher J Darus Ph: 207-885-7565
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Deborah K. Armstrong Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
  Bethesda
 National Naval Medical Center
 Michael P Stany Ph: 301-319-2100
Massachusetts
  Boston
 Dana-Farber/Brigham and Women's Cancer Center
 Suzanne George Ph: 866-790-4500
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Suzanne George Ph: 866-790-4500
  Springfield
 Baystate Medical Center
 Tashanna K Myers Ph: 413-794-3565
  Email: tamara.wrenn@baystatehealth.org
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
  Detroit
 Wayne State University
 Robert T. Morris Ph: 313-576-9363
  Kalamazoo
 West Michigan Cancer Center
 Sunil Nagpal Ph: 269-373-7458
  Monroe
 Community Cancer Center of Monroe
 Rex B Mowat Ph: 517-265-0116
Mississippi
  Jackson
 St. Dominic Cancer Center
 Donald P Seago Ph: 601-200-3300
 University of Mississippi Cancer Clinic
 James Tate Thigpen Ph: 601-815-6700
Missouri
  Bonne Terre
 Parkland Health Center-Bonne Terre
 Alan Philip Lyss Ph: 800-392-0936
  Cape Girardeau
 Southeast Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Jefferson City
 Goldschmidt Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Saint Louis
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Gardner Mutch Ph: 800-600-3606
  Email: info@ccadmin.wustl.edu
  Sainte Genevieve
 Sainte Genevieve County Memorial Hospital
 Alan Philip Lyss Ph: 800-392-0936
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Sullivan
 Missouri Baptist Sullivan Hospital
 Alan Philip Lyss Ph: 800-392-0936
  Sunset Hills
 Missouri Baptist Outpatient Center-Sunset Hills
 Alan Philip Lyss 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
  Omaha
 Fred and Pamela Buffett Cancer Center
 Kerry Rodabaugh Ph: 800-999-5465
 Kerry Rodabaugh Ph: 800-999-5465
 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
  Reno
 Renown Institute for Cancer at Renown Regional Medical Center
 Peter C Lim Ph: 866-513-8227
 Peter C Lim Ph: 866-513-8227
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Leslie R. DeMars Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 David P. Warshal Ph: 856-325-6757
  Mount Holly
 Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County
 Randolph B Deger Ph: 888-847-8823
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 David P. Warshal Ph: 856-325-6757
 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
 Carolyn Y. Muller Ph: 505-272-6972
 University of New Mexico Cancer Center
 Carolyn Y. Muller Ph: 505-272-6972
New York
  Albany
 Women's Cancer Care Associates
 Thomas P Morrissey Ph: 518-458-1390
  New York
 Memorial Sloan-Kettering Cancer Center
 Martee L. Hensley Ph: 212-639-7202
  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
  Asheboro
 Randolph Hospital
 James M Granfortuna Ph: 336-832-0821
  Burlington
 Alamance Cancer Center at Alamance Regional Medical Center
 James M Granfortuna Ph: 336-832-0821
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 John M McDonald Ph: 704-384-5369
  Durham
 Duke Cancer Institute
 Angeles Alvarez Secord Ph: 888-275-3853
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 James M Granfortuna Ph: 336-832-0821
  Mebane
 Cone Heath Cancer Center at Mebane
 James M Granfortuna Ph: 336-832-0821
  Reidsville
 Annie Penn Cancer Center
 James M Granfortuna Ph: 336-832-0821
  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
Ohio
  Akron
 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
  Canton
 Aultman Cancer Center at Aultman Hospital
 Michael P. Hopkins Ph: 330-363-6891
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Cincinnati
 Oncology Hematology Care Inc - Western Hills
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Anderson
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Blue Ash
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Kenwood
 Howard M. Gross Ph: 937-775-1350
 Oncology Hematology Care, Incorporated - Mt. Auburn/Taft Road
 Howard M. Gross Ph: 937-775-1350
  Cleveland
 Case Comprehensive Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 David M O'Malley Ph: 800-293-5066
  Email: Jamesline@osumc.edu
 Martee L. Hensley
  Email: hensleym@mskcc.org
 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
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 937-775-1350
 Good Samaritan Hospital
 Howard M. Gross Ph: 937-775-1350
 Samaritan North Cancer Care Center
 Howard M. Gross Ph: 937-775-1350
  Delaware
 Delaware Health Center
 J. Philip Kuebler Ph: 614-566-3275
 Delaware Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Fairfield
 Oncology Hematology Care, Incorporated - Fairfield Healthplex
 Howard M. Gross Ph: 937-775-1350
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 937-775-1350
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 937-775-1350
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 937-775-1350
  Kettering
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 937-775-1350
  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
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  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
 Newark Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
  Oregon
 St. Charles Mercy Hospital
 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
  Toledo
 CCOP - Toledo Community Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 937-775-1350
  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
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
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Parviz Hanjani Ph: 215-481-2402
  Beaver
 UPMC Cancer Center at Beaver Medical Center
 Alexander B Olawaiye Ph: 412-647-2811
  Bethlehem
 St. Luke's Cancer Network at St. Luke's Hospital
 Nicholas P Taylor Ph: 610-954-3582
  Email: infolink@slhn.org
  Clairton
 UPMC Cancer Center at Jefferson Regional Medical Center
 Alexander B Olawaiye Ph: 412-647-2811
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Radhika P Gogoi Ph: 570-271-5251
  Ephrata
 Ephrata Cancer Center at Ephrata Community Hospital
 Mark A Miller Ph: 877-441-7957
 Mark A Miller Ph: 877-441-7957
  Gettysburg
 Adams Cancer Center
 Mark A Miller Ph: 877-441-7957
  Greensburg
 UPMC Cancer Center - Arnold Palmer Pavilion
 Alexander B Olawaiye Ph: 412-647-2811
  Hanover
 Cherry Tree Cancer Center
 Mark A Miller Ph: 877-441-7957
  Hazleton
 Geisinger Hazleton Cancer Center
 Radhika P Gogoi Ph: 570-271-5251
  Johnstown
 UPMC Cancer Center at the John P. Murtha Pavilion
 Alexander B Olawaiye Ph: 412-647-2811
  McKeesport
 UPMC Cancer Center at UPMC McKeesport
 Alexander B Olawaiye Ph: 412-647-2811
  Moon Township
 UPMC - Moon
 Alexander B Olawaiye Ph: 412-647-2811
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Sujana Movva Ph: 215-728-4790
 Temple Cancer Center at Temple University Hospital
 Enrique Hernandez Ph: 215-728-2983
  Pittsburgh
 St. Clair Memorial Hospital Cancer Center
 Alexander B Olawaiye Ph: 412-647-2811
 UPMC - Shadyside
 Alexander B Olawaiye Ph: 412-647-2811
 UPMC Cancer Center at Magee-Womens Hospital
 Alexander B Olawaiye Ph: 412-647-2811
 UPMC Cancer Center at UPMC Passavant
 Alexander B Olawaiye Ph: 412-647-2811
 UPMC Cancer Center at UPMC Presbyterian
 Alexander B Olawaiye Ph: 412-647-2811
 UPMC Cancer Center at UPMC St. Margaret
 Alexander B Olawaiye Ph: 412-647-2811
 UPMC Cancer Centers
 Alexander B Olawaiye Ph: 412-647-2811
  Seneca
 UPMC Cancer Center at UPMC Northwest
 Alexander B Olawaiye Ph: 412-647-2811
  State College
 Geisinger Medical Group - Scenery Park
 Radhika P Gogoi Ph: 570-271-5251
  Uniontown
 UPMC Cancer Center - Uniontown
 Alexander B Olawaiye Ph: 412-647-2811
  Washington
 Washington Hospital Cancer Center
 Alexander B Olawaiye Ph: 412-647-2811
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Bernice L Robinson-Bennett Ph: 610-988-9323
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Radhika P Gogoi Ph: 570-271-5251
  Wynnewood
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
  York
 WellSpan Health
 Mark A Miller Ph: 877-441-7957
 York Cancer Center at Apple Hill Medical Center
 Mark A Miller Ph: 877-441-7957
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Carolyn K McCourt Ph: 800-600-3606
  Email: info@siteman.wustl.edu
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Jennifer L Young Pierce Ph: 843-792-9321
  Easley
 Cancer Centers of the Carolinas - Easley
 Jeffrey W Elder Ph: 864-679-3966
  Greenville
 Cancer Centers of the Carolinas - Andrews
 Jeffrey W Elder Ph: 864-679-3966
 Cancer Centers of the Carolinas - Faris Road
 Jeffrey W Elder Ph: 864-679-3966
 Cancer Centers of the Carolinas - Grove Commons
 Jeffrey W Elder Ph: 864-679-3966
 CCOP - Greenville
 Jeffrey W Elder Ph: 864-679-3966
 Greenville Memorial Hospital
 Jeffrey W Elder Ph: 864-679-3966
  Greer
 Cancer Centers of the Carolinas - Greer Radiation Oncology
 Jeffrey W Elder Ph: 864-679-3966
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey W Elder Ph: 864-679-3966
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey W Elder Ph: 864-679-3966
Tennessee
  Knoxville
 U.T. Medical Center Cancer Institute
 Larry C Kilgore Ph: 865-544-9773
Texas
  Dallas
 Parkland Memorial Hospital
 David Scott Miller Ph: 214-648-7097
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 David Scott Miller Ph: 214-648-7097
Washington
  Auburn
 Auburn Regional Center for Cancer Care
 John A Keech Ph: 907-458-5380
  Bellevue
 Overlake Cancer Center at Overlake Hospital Medical Center
 John A Keech Ph: 907-458-5380
  Centralia
 Providence Centralia Hospital
 John A Keech Ph: 907-458-5380
  Everett
 Providence Regional Cancer Partnership
 John A Keech Ph: 907-458-5380
  Lacey
 Western Washington Oncology, Incorporated, PS at Western Washington Cancer Center
 John A Keech Ph: 907-458-5380
  Puyallup
 Good Samaritan Cancer Center
 John A Keech Ph: 907-458-5380
  Tacoma
 MultiCare Regional Cancer Center at Tacoma General Hospital
 John A Keech Ph: 907-458-5380
 Northwest Medical Specialties, PLLC - Tacoma
 John A Keech Ph: 907-458-5380
  Walla Walla
 St. Mary Regional Cancer Center at St. Mary Medical Center
 Robert Craig Quackenbu Ph: 800-422-6237
Wisconsin
  Green Bay
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Johnson Creek
 UW Cancer Center Johnson Creek
 David M Kushner Ph: 877-405-6866
  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
  Marinette
 Vince Lombardi Cancer Clinic - Marinette
 Ali Mahdavi Ph: 414-649-5717
  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
 Ali Mahdavi Ph: 414-649-5717
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Ali Mahdavi Ph: 414-649-5717
  Sheboygan
 Vince Lombardi Cancer Clinic - Sheboygan
 Ali Mahdavi Ph: 414-649-5717
  Summit
 Aurora Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Two Rivers
 Vince Lombardi Cancer Clinic - Two Rivers
 Ali Mahdavi Ph: 414-649-5717
Wyoming
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
United Kingdom
England
  Cambridge
 Addenbrookes Hospital-Medical School
 Helen Hatcher Ph: 888-823-5923
  Email: ctsucontact@westat.com
  London
 Institute of Cancer Research - London
 Charlotte Benson Ph: 888-823-5923
  Email: ctsucontact@westat.com
Scotland
  Glasgow
 Beatson West of Scotland Cancer Centre
 Nicholas S Reed Ph: 888-823-5923
  Email: ctsucontact@westat.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01533207
ClinicalTrials.gov processed this data on November 12, 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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