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Clinical Trials (PDQ®)

  • First Published: 2/20/2004
  • Last Modified: 2/9/2012

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Phase III Randomized Study of Zoledronate for the Prevention of Skeletal-Related Events in Patients With Prostate Cancer and Bone Metastases Undergoing Androgen Deprivation Therapy

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCICALGB-90202
ECOG-CALGB-90202, NCT00079001, SWOG-CALGB-90202, CAN-NCIC-PRC2

Special Category: CTSU trial, NCI Web site featured trial

Objectives

Primary

  1. Compare the time to first skeletal-related events in patients with prostate cancer and bone metastases undergoing androgen deprivation therapy when treated with zoledronate vs placebo.

Secondary

  1. Compare the overall and progression-free survival of patients treated with these regimens.
  2. Compare the toxic effects in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed adenocarcinoma of the prostate

  • No small cell, neuroendocrine, or transitional cell carcinomas

  • At least 1 bone metastasis by bone scan, MRI, CT scan, or plain radiographs
    • Indeterminate lesions should be confirmed by a second imaging method
    • At least 1 bone metastasis with no prior irradiation

  • Concurrent androgen deprivation therapy required, defined as any of the following:
    • Bilateral orchiectomy
    • Gonadotropin-releasing hormone (GnRH) agonist with or without an antiandrogen

Prior/Concurrent Therapy:

Biologic therapy

  • Concurrent standard biologic response modifiers allowed during open-label therapy only

Chemotherapy

  • Concurrent standard cytotoxic chemotherapy allowed during open-label therapy only

Endocrine therapy

  • See Disease Characteristics
  • Prior neoadjuvant and/or adjuvant hormonal therapy allowed provided duration of therapy was no more than 6 months AND therapy was discontinued more than 6 months before study entry
  • No more than 6 months since initiation of any of the following hormonal therapies:
    • Orchiectomy
    • GnRH agonist (e.g., leuprolide, goserelin, or triptorelin)
    • Estrogen therapy
    • Antiandrogens (e.g., bicalutamide, flutamide, or nilutamide)
    • Any other therapy known to lower testosterone levels or inhibit testosterone effect
  • No intermittent androgen deprivation therapy except for patients concurrently enrolled on SWOG-9346
  • Concurrent palliative corticosteroids allowed during open-label therapy only
  • Concurrent standard hormonal agents allowed during open-label therapy only

Radiotherapy

  • See Disease Characteristics
  • No prior radiopharmaceuticals
  • At least 4 weeks since prior radiotherapy
  • Concurrent standard radiotherapy to extraskeletal tumor sites allowed during open-label therapy only

Surgery

  • See Disease Characteristics

Other

  • No prior bisphosphonates
  • No prior denosumab
  • No other concurrent agents expected to alter osteoclast activity (e.g., denosumab, calcitonin, mithramycin, gallium nitrate, or any other bisphosphonate)
  • Concurrent daily supplemental elemental calcium (500 mg) and a multivitamin containing cholecalciferol (Vitamin D) (400 IU) OR a combination tablet containing both recommended
  • Concurrent standard marketed antineoplastic therapies allowed during open-label therapy only

Patient Characteristics:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Creatinine clearance ≥ 30 mL/min
  • Corrected calcium ≥ 8.0 mg/dL and < 11.6 mg/dL

Other

  • Fertile patients must use effective contraception

Expected Enrollment

680

A total of 680 patients (340 per treatment arm) will be accrued for this study within 4 years.

Outcomes

Primary Outcome(s)

Time to first skeletal related event

Secondary Outcome(s)

Overall survival
Progression-free survival
Toxicity

Outline

This is a randomized, double-blind, placebo-controlled, multicenter study followed by an open-label study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior skeletal-related event (no vs yes), and serum alkaline phosphatase (< upper limit of normal [ULN] vs ≥ ULN). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive zoledronate IV over 15 minutes on day 1.

  • Arm II: Patients receive placebo IV over 15 minutes on day 1.

In both arms, courses repeat every 4 weeks in the absence of disease progression or a skeletal-related event. All patients receive concurrent androgen deprivation therapy. Patients also receive oral calcium and cholecalciferol (vitamin D) supplements daily.

Patients progressing to androgen-independent prostate cancer proceed to open-label therapy comprising zoledronate IV over 15 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or a skeletal-related event.

Patients are followed periodically for approximately 10 years after randomization.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Matthew Smith, MD, Protocol chair
Ph: 617-724-5257; 877-726-5130

Southwest Oncology Group

Nirmala Bhoopalam, MD, Protocol chair
Ph: 708-202-2782
Email: nirmala.bhoopalam@med.va.gov

Eastern Cooperative Oncology Group

Christopher Sweeney, MBBS, Protocol chair
Ph: 317-274-3515; 888-600-4822
Email: chsweene@iupui.edu

NCIC-Clinical Trials Group

Fred Saad, MD, FRCS, Protocol chair
Ph: 514-890-8000 ext 27466
Email: fred.saad.chum@ssss.gouv.qc.ca

Trial Sites

U.S.A.
Alabama
  Mobile
 Providence Cancer Center at Providence Hospital
 Thaddeus Beeker
Ph: 251-633-1890
Arkansas
  Ft. Smith
 Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
 John Wells, MD
Ph: 479-484-4700
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Ph: 501-686-8274
California
  Pomona
 Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
 Clinical Trials Office - Robert and Beverly Lewis Family Cancer Care Center
Ph: 909-865-9555
  Saint Helena
 Saint Helena Hospital
 Gregory Smith
Ph: 707-963-3611
  Salinas
 Salinas Valley Memorial Hospital
 Shehzad Aziz, MD
Ph: 831-755-1701
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center
Ph: 877-827-3222
  Whittier
 Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
 Jack Freimann, MD
Ph: 562-945-6770
Connecticut
  New Haven
 Yale Cancer Center
 Clinical Trials Office - Yale Cancer Center
Ph: 203-785-5702
  West Haven
 Veterans Affairs Medical Center - West Haven
 Michal Rose, MD
Ph: 203-937-3421
Florida
  Leesburg
 Leesburg Regional Medical Center
 Pablo Reyes, Jr.
Ph: 352-323-5762
Georgia
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 Mark Taylor, MD
Ph: 912-354-6187
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey Berenberg, MD
Ph: 808-433-4089
  Honolulu
 Cancer Research Center of Hawaii
 Clinical Trials Office - Cancer Research Center of Hawaii
Ph: 808-586-2979
 Hawaii Medical Center - East
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Kapiolani Medical Center for Women and Children
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Straub Clinic and Hospital, Incorporated
 Jeffrey Berenberg, MD
Ph: 808-433-4089
  Wailuku
 Pacific Cancer Institute - Maui
 Jeffrey Berenberg, MD
Ph: 808-433-4089
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 David Graham
Ph: 630-499-2400
866-426-7539
  Chicago
 Louis A. Weiss Memorial Hospital
 Clinical Trials Office - Louis A. Weiss Memorial Hospital
Ph: 773- 564-5044
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
 University of Illinois Cancer Center
 Clinical Trial Office - University of Illinois Cancer Center
Ph: 312-355-3046
 Veterans Affairs Medical Center - Chicago Westside Hospital
 David Peace, MD
Ph: 312-413-1507
  Elmhurst
 Elmhurst Memorial Hospital
 Robert Eisner
Ph: 630-833-1400
  Hines
 Veterans Affairs Medical Center - Hines
 Nirmala Bhoopalam, MD
Ph: 708-202-2782
  Kankakee
 Provena St. Mary's Regional Cancer Center - Kankakee
 Riaz Elahi, MD
Ph: 708-873-4500
  La Grange
 La Grange Memorial Hospital
 Clinical Trials Office - La Grange Memorial Hospital
Ph: 630-856-7526
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Clinical Trials Office - Cardinal Bernardin Cancer Center
Ph: 708-226-4357
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Clinical Trials Office - Carle Cancer Center
Ph: 800-446-5532
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Elkhart General Hospital
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - Elkhart
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Clinical Trials Office - Indiana University Cancer Center
Ph: 317-274-2552
 William N. Wishard Memorial Hospital
 Noah Hahn
Ph: 317-639-6671
  Kokomo
 Howard Community Hospital
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Michigan City
 Saint Anthony Memorial Health Centers
 David Graham
Ph: 219-879-8511
  Mishawaka
 Michiana Hematology-Oncology, PC - South Bend
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Saint Joseph Regional Medical Center
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  South Bend
 CCOP - Northern Indiana CR Consortium
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Memorial Hospital of South Bend
 Clinical Trials Office - Memorial Hospital of South Bend
Ph: 800-284-7370
 Michiana Hematology-Oncology, PC - South Bend
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Westville
 Michiana Hematology Oncology PC - La Porte
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
Iowa
  Council Bluffs
 Heartland Oncology and Hematology
 John Okerbloom, MD
Ph: 712-322-4136
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Cancer Information Service
Ph: 800-237-1225
 Veterans Affairs Medical Center - Iowa City
 Daniel Vaena
Ph: 319-338-0581
800-637-0128
  Waterloo
 Covenant Cancer Treatment Center
 Clinical Trials Office - Covenant Cancer Treatment Center
Ph: 319-272-2070
Kansas
  Topeka
 Cotton-O'Neil Cancer Center
 Clinical Trials Office - Cotton-O'Neil Cancer Center
Ph: 785-270-4963
Louisiana
  Baton Rouge
 Mary Bird Perkins Cancer Center - Baton Rouge
 Robert Veith
Ph: 225-767-0847
  Monroe
 Louisiana State University Health Sciences Center - Monroe
 Donald Elmajian, MD
Ph: 318-813-1200
  New Orleans
 MBCCOP - LSU Health Sciences Center
 Robert Veith
Ph: 504-568-5151
 Medical Center of Louisiana - New Orleans
 Robert Veith
Ph: 504-903-2311
  Shreveport
 Feist-Weiller Cancer Center at Louisiana State University Health Sciences
 Clinical Trials Office - Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Ph: 318-813-1412
 Highland Clinic
 Donald Elmajian, MD
Ph: 318-813-1200
Maryland
  Baltimore
 Greenebaum Cancer Center at University of Maryland Medical Center
 Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center
Ph: 800-888-8823
 Veterans Affairs Medical Center - Baltimore
 Arif Hussain, MD
Ph: 410-328-7225
  Hagerstown
 John R. Marsh Cancer Center at Washington County Hospital
 Michael McCormack
Ph: 301-665-4650
Massachusetts
  Boston
 Dana-Farber/Brigham and Women's Cancer Center
 Clinical Trials Office
Ph: 617-724-5200
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Matthew Smith, MD
Ph: 617-724-5257
 Massachusetts General Hospital
 Clinical Trials Office - Massachusetts General Hospital
Ph: 877-726-5130
  Lowell
 Lowell General Hospital
 Matthew Smith, MD
Ph: 617-724-5257
  Milford
 Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
 Matthew Smith, MD
Ph: 617-724-5257
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center
Ph: 517-265-0116
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Robert Chapman, MD
Ph: 313-916-1332
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Iron Mountain
 Dickinson County Healthcare System
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Kalamazoo
 Borgess Medical Center
 Raymond Lord, MD
Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Lord, MD
Ph: 269-373-7458
 West Michigan Cancer Center
 Clinical Trials Office - West Michigan Cancer Center
Ph: 269-373-7458
  Monroe
 Community Cancer Center of Monroe
 Rex Mowat
Ph: 734-242-7902
 Mercy Memorial Hospital - Monroe
 Rex Mowat
Ph: 734-240-8400
  Niles
 Michiana Hematology Oncology PC - Niles
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Duluth
 CCOP - Duluth
 Daniel Nikcevich, MD, PhD
Ph: 218-786-3625
 Duluth Clinic Cancer Center - Duluth
 Clinical Trials Office - Duluth Clinic Cancer Center - Duluth
Ph: 218-786-3308
 Miller - Dwan Medical Center
 Daniel Nikcevich, MD, PhD
Ph: 218-786-3625
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Hutchinson
 Hutchinson Area Health Care
 Patrick Flynn, MD
Ph: 612-863-8585
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
 Minnesota Oncology Hematology, PA - Maplewood
 Patrick Flynn, MD
Ph: 612-863-8585
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Clinical Trials Office - Hennepin County Medical Center - Minneapolis
Ph: 612-873-5911
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick Flynn, MD
Ph: 612-863-8585
 Park Nicollet Cancer Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Saint Paul
 United Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  St. Paul
 Regions Hospital Cancer Care Center
 Clinical Trials Office - Regions Hospital Cancer Care Center
Ph: 651-254-1517
  Stillwater
 Lakeview Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Waconia
 Ridgeview Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Patrick Flynn, MD
Ph: 612-863-8585
Missouri
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Joel Picus, MD
Ph: 314-362-5737
Montana
  Billings
 Billings Clinic - Downtown
 Clinical Trials Office - Billings Clinic - Downtown
Ph: 800-996-2663
  Email: research@billingsclinic.org
 CCOP - Montana Cancer Consortium
 Benjamin Marchello, MD
Ph: 406-238-6290
 Hematology-Oncology Centers of the Northern Rockies - Billings
 Benjamin Marchello, MD
Ph: 406-238-6290
 St. Vincent Healthcare Cancer Care Services
 Benjamin Marchello, MD
Ph: 406-238-6290
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Butte
 St. James Healthcare Cancer Care
 Benjamin Marchello, MD
Ph: 406-238-6290
  Great Falls
 Big Sky Oncology
 Clinical Trial Office - Big Sky Oncology
Ph: 406-731-8217
 Great Falls Clinic - Main Facility
 Benjamin Marchello, MD
Ph: 406-238-6290
 Sletten Cancer Institute at Benefis Healthcare
 Grant Harrer, MD, FACP, CCTI
Ph: 406-731-8100
  Helena
 St. Peter's Hospital
 Benjamin Marchello, MD
Ph: 406-238-6290
  Kalispell
 Glacier Oncology, PLLC
 Benjamin Marchello, MD
Ph: 406-238-6290
 Kalispell Medical Oncology at KRMC
 Benjamin Marchello, MD
Ph: 406-238-6290
 Kalispell Regional Medical Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Ph: 406-329-7029
Nebraska
  Grand Island
 Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
 Jue Wang
Ph: 308-398-5450
800-998-2119
  Lincoln
 Cancer Resource Center - Lincoln
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
  North Platte
 Callahan Cancer Center at Great Plains Regional Medical Center
 Clinical Trials Office - Callahan Cancer Center at Great Plains Regional Medical Center
Ph: 308-696-7864
  Omaha
 Alegant Health Cancer Center at Bergan Mercy Medical Center
 Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center
Ph: 402-398-6060
 CCOP - Missouri Valley Cancer Consortium
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
 Creighton University Medical Center
 Clinical Trials Office - Creighton University Medical Center
Ph: 402-280-4100
 Immanuel Medical Center
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
 Methodist Estabrook Cancer Center
 Robert Langdon, MD
Ph: 402-399-8762
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Ph: 800-999-5465
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Ellerton, MD, CM
Ph: 702-384-0013
 Nevada Cancer Institute
 Clinical Trials Office - Nevada Cancer Institute
Ph: 702-822-5136
 University Medical Center of Southern Nevada
 John Ellerton, MD, CM
Ph: 702-384-0013
New Hampshire
  Concord
 New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
 Douglas Weckstein, MD
Ph: 603-622-6484
  Exeter
 Center for Cancer Care at Exeter Hospital
 Michael Buff
Ph: 603-580-6636
  Hooksett
 New Hampshire Oncology - Hematology, PA - Hooksett
 Douglas Weckstein, MD
Ph: 603-622-6484
  Londonderry
 Dana-Farber Cancer Institute at Londonderry
 Matthew Smith, MD
Ph: 617-724-5257
  Manchester
 Elliot Regional Cancer Center at Elliot Hospital
 Douglas Weckstein, MD
Ph: 603-622-6484
New Jersey
  East Orange
 Veterans Affairs Medical Center - East Orange
 Basil Kasimis, MD, DSc
Ph: 973-395-7809
  Vineland
 Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
 Clinical Trials Office - Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Ph: 856-641-7933
New Mexico
  Albuquerque
 Lovelace Medical Center - Downtown
 Richard Lauer
Ph: 505-727-8000
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
New York
  Brooklyn
 Kings County Hospital Center
 Robert Lewis
Ph: 718-245-3901
 SUNY Downstate Medical Center
 Robert Lewis
Ph: 718-270-4293
 Veterans Affairs Medical Center - Brooklyn
 Andrea Wiesel Leaf, MD
Ph: 718-630-3691
  Buffalo
 Roswell Park Cancer Institute
 Clinical Trials Office - Roswell Park Cancer Institute
Ph: 877-275-7724
 Veterans Affairs Medical Center - Buffalo
 Lynn Steinbrenner, MD
Ph: 716-862-3191
  East Syracuse
 CCOP - Hematology-Oncology Associates of Central New York
 Jeffrey Kirshner, MD
Ph: 315-472-7504
  New York
 Memorial Sloan-Kettering Cancer Center
 Michael Morris, MD
Ph: 646-422-4469
 New York Weill Cornell Cancer Center at Cornell University
 Clinical Trials Office - New York Weill Cornell Cancer Center at Cornell University
Ph: 212-746-1848
  Syracuse
 SUNY Upstate Medical University Hospital
 Clinical Trials Office - SUNY Upstate Medical University Hospital
Ph: 315-464-5476
 Veterans Affairs Medical Center - Syracuse
 Ajeet Gajra, MD
Ph: 315-425-4666
North Carolina
  Durham
 Duke Cancer Institute
 Clinical Trials Office - Duke Cancer Institute
Ph: 888-275-3853
  Kinston
 Kinston Medical Specialists
 Peter Watson, MD
Ph: 252-559-2200ext.201
  Lumberton
 Southeastern Regional Medical Center
 Jeffrey Crawford, MD
Ph: 919-681-9509
  Oxford
 Granville Medical Center
 Jeffrey Crawford, MD
Ph: 919-681-9509
  Raleigh
 Duke Health Raleigh Hospital
 Jeffrey Crawford, MD
Ph: 919-681-9509
  Roxboro
 Person Memorial Hospital
 Jeffrey Crawford, MD
Ph: 919-681-9509
North Dakota
  Bismarck
 Bismarck Cancer Center
 Edward Wos, DO
Ph: 701-323-5741
 Medcenter One Hospital Cancer Care Center
 Edward Wos, DO
Ph: 701-323-5741
 Mid Dakota Clinic, PC
 Clinical Trials Office - Mid Dakota Clinic, PC
Ph: 701-530-6950
 St. Alexius Medical Center Cancer Center
 Clinical Trials Office - St. Alexius Medical Center Cancer Center
Ph: 701-530-6950
Ohio
  Bowling Green
 Wood County Oncology Center
 Rex Mowat
Ph: 419-352-9498
  Cleveland
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce Averbook, MD, FACS
Ph: 216-778-4795
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Ohio State University Cancer Clinical Trial Matching Service
Ph: 866-627-7616
  Email: osu@emergingmed.com
  Lima
 Lima Memorial Hospital
 Rex Mowat
Ph: 419-228-3335
 St. Rita's Medical Center
 Clinical Trials Office - St. Rita's Medical Center
Ph: 419-226-9617
  Maumee
 Northwest Ohio Oncology Center
 Rex Mowat
Ph: 419-891-5600
 Rex Mowat
Ph: 419-891-5600
  Norwalk
 Fisher-Titus Medical Center
 Rex Mowat
Ph: 419-668-8101
800-589-3862
  Oregon
 St. Charles Mercy Hospital
 Rex Mowat
Ph: 419-696-7200
 Toledo Clinic - Oregon
 Rex Mowat
Ph: 419-691-4235
  Sandusky
 North Coast Cancer Care, Incorporated
 Rex Mowat
Ph: 419-626-9090
  Sylvania
 Flower Hospital Cancer Center
 Clinical Trials Office - Flower Hospital Cancer Center
Ph: 419-824-1842
  Tiffin
 Mercy Hospital of Tiffin
 Rex Mowat
Ph: 419-447-3130
  Toledo
 CCOP - Toledo Community Hospital
 Rex Mowat
Ph: 419-843-6147
 Medical University of Ohio Cancer Center
 Clinical Trials Office - Medical University of Ohio Cancer Center
Ph: 419-383-6583
 St. Anne Mercy Hospital
 Rex Mowat
Ph: 419-407-2663
 St. Vincent Mercy Medical Center
 Rex Mowat
Ph: 419-251-4515
 Toledo Clinic, Incorporated - Main Clinic
 Rex Mowat
Ph: 419-479-5605
 Toledo Hospital
 Clinical Trials Office - Toledo Hospital
Ph: 419-824-1842
  Wauseon
 Fulton County Health Center
 Clinical Trials Office - Fulton County Health Center
Ph: 419-330-2708
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Shubham Pant
Ph: 405-271-6822
Oregon
  Coos Bay
 Bay Area Hospital
 Bret Cook, MD
Ph: 541-267-5151
  Portland
 Kaiser Permanente Health Care - Portland
 Nagendra Tirumali, MD
Ph: 503-331-6500
Pennsylvania
  Scranton
 Hematology and Oncology Associates of Northeastern Pennsylvania
 Martin Hyzinski, MD
Ph: 570-558-3020
 Mercy Hospital Cancer Center - Scranton
 Martin Hyzinski, MD
Ph: 570-558-3020
  Williamsport
 Susquehanna Cancer Center at Divine Providence Hospital
 Warren Robinson, Jr.
Ph: 570-326-8000
South Carolina
  Greenville
 CCOP - Greenville
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
 Greenville Hospital Cancer Center
 Clinical Trials Office - Greenville Hospital Cancer Center
Ph: 864-241-6251
  Greenwood
 Self Regional Cancer Center at Self Regional Medical Center
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
Tennessee
  Nashville
 MBCCOP - Meharry Medical College - Nashville
 Steven Wolff, MD
Ph: 615-327-6277
Texas
  Houston
 Baylor University Medical Center - Houston
 Martha Mims
Ph: 713-798-8070
 Ben Taub General Hospital
 Martha Mims
Ph: 713-873-2000
 St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
 Martha Mims
Ph: 832-355-3490
 Veterans Affairs Medical Center - Houston
 Martha Mims
Ph: 713-794-7111
800-553-2278
Utah
  American Fork
 American Fork Hospital
 R. Jeffrey Lee, MD
Ph: 801-408-1146
  Cedar City
 Sandra L. Maxwell Cancer Center
 R. Jeffrey Lee, MD
Ph: 801-408-1146
  Logan
 Logan Regional Hospital
 R. Jeffrey Lee, MD
Ph: 801-408-1146
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 R. Jeffrey Lee, MD
Ph: 801-408-1146
  Ogden
 Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
 Clinical Trials Office - McKay-Dee Hospital Center
Ph: 801 387-7426
  Provo
 Utah Valley Regional Medical Center - Provo
 Clinical Trials Office - Utah Valley Regional Medical Center - Provo
Ph: 801-357-7965
  Saint George
 Dixie Regional Medical Center - East Campus
 Clinical Trials Office - Dixie Regional Medical Center - East Campus
Ph: 435-688-4167
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Clinical Trials Office - Huntsman Cancer Institute at University of Utah
Ph: 801-581-4477
  Email: clinical.trials@hci.utah.edu
 LDS Hospital
 R. Jeffrey Lee, MD
Ph: 801-408-1146
 Utah Cancer Specialists at UCS Cancer Center
 R. Jeffrey Lee, MD
Ph: 801-408-1146
Vermont
  Berlin
 Mountainview Medical
 Steven Ades
Ph: 802-223-6196
  Burlington
 Fletcher Allen Health Care - University Health Center Campus
 Clinical Trials Office - Fletcher Allen Health Care
Ph: 802-656-8990
Virginia
  Fredericksburg
 Fredericksburg Oncology, Incorporated
 Rex Mowat
Ph: 540-368-0500
  Lynchburg
 Lynchburg Hematology-Oncology Clinic
 John Leach MacNeill, MD
Ph: 434-947-5925
Washington
  Anacortes
 Island Hospital Cancer Care Center at Island Hospital
 Saul Rivkin, MD
Ph: 206-386-2441
  Bellingham
 St. Joseph Cancer Center
 Saul Rivkin, MD
Ph: 206-386-2441
  Bremerton
 Olympic Hematology and Oncology
 Saul Rivkin, MD
Ph: 206-386-2441
  Burien
 Highline Medical Center Cancer Center
 Saul Rivkin, MD
Ph: 206-386-2441
  Kennewick
 Columbia Basin Hematology
 Saul Rivkin, MD
Ph: 206-386-2441
  Mount Vernon
 Skagit Valley Hospital Cancer Care Center
 Saul Rivkin, MD
Ph: 206-386-2441
  Seattle
 Group Health Central Hospital
 Clinical Trials Office - Group Health Central Hospital
Ph: 206-287-2900
 Minor and James Medical, PLLC
 Saul Rivkin, MD
Ph: 206-386-2441
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Saul Rivkin, MD
Ph: 206-386-2441
 University Cancer Center at University of Washington Medical Center
 Saul Rivkin, MD
Ph: 206-386-2441
  Sedro-Woolley
 North Puget Oncology at United General Hospital
 Saul Rivkin, MD
Ph: 206-386-2441
  Spokane
 Cancer Care Northwest - Spokane South
 Clinical Trials Office - Cancer Care Northwest - Spokane South
Ph: 509-228-1083
 Evergreen Hematology and Oncology, PS
 Saul Rivkin, MD
Ph: 206-386-2441
 Rockwood Clinic Cancer Treatment Center
 Clinical Trials Office - Rockwood Clinic Cancer Treatment Center
Ph: 509-838-2531 ext. 6880
  Wenatchee
 Wenatchee Valley Medical Center
 Clinical Trials Office - Wenatchee Valley Medical Center
Ph: 509-665-5800
Wisconsin
  Antigo
 Langlade Memorial Hospital
 Christopher Peterson
Ph: 715-623-2331
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
 St. Mary's Hospital Medical Center - Green Bay
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
 St. Vincent Hospital Regional Cancer Center
 Clinical Trials Office - St. Vincent Hospital Regional Cancer Center
Ph: 920-433-8889
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Clinical Trials Office - Holy Family Memorial Medical Center Cancer Care Center
Ph: 920-320-2749
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Milwaukee
 Wheaton Franciscan Cancer Care - St. Joseph
 Jonathan Treisman, MD
Ph: 414-385-3086
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Sheboygan
 St. Nicholas Hospital
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Wausau
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Clinical Trials Office - University of Wisconsin Cancer Center
Ph: 608-262-5223
  Wisconsin Rapids
 Riverview UW Cancer Center at Riverview Hospital
 Ron Kirschling, MD, FACP
Ph: 715-421-7442
Wyoming
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Marchello, MD
Ph: 406-238-6290
Canada
Alberta
  Edmonton
 Cross Cancer Institute at University of Alberta
 Peter Venner
Ph: 780-432-8771
British Columbia
  Vancouver
 University of British Columbia
 Martin Gleave, MD
Ph: 604-875-5003
Ontario
  London
 London Regional Cancer Program at London Health Sciences Centre
 Joseph Chin
Ph: 519-685-8615
Quebec
  Montreal
 Hopital Notre-Dame du CHUM
 Fred Saad, MD, FRCS
Ph: 514-890-8000ext27466

Related Information

Featured trial article

Registry Information
Official Title A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone
Trial Start Date 2004-01-15
Trial Completion Date 2008-01-11 (estimated)
Registered in ClinicalTrials.gov NCT00079001
Date Submitted to PDQ 2004-01-14
Information Last Verified 2012-02-09
NCI Grant/Contract Number CA31946

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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