Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer
OBJECTIVES:
Primary
- Compare the efficacy of zoledronate, vitamin D, and calcium with or without strontium
chloride Sr 89 or samarium Sm 153 lexidronam pentasodium, in terms of preventing or
delaying the time to development of malignant skeletal-related events (SREs) (defined
as a pathological bone fracture, spinal cord compression, surgery to bone, or radiation
to bone) in patients with bone metastases secondary to prostate, lung, or breast
cancer.
Secondary
- Compare the rate of SREs at 1 year in patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
- Compare quality of life of patients treated with these regimens.
- Compare the effect of these regimens on pain control in these patients.
- Evaluate resource utilization and cost effectiveness of these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to primary disease site (prostate vs breast vs lung) and number of bone metastases
(≤ 2 vs > 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive zoledronate IV over 15 minutes once a month. Patients also
receive oral vitamin D and oral calcium once daily. Treatment continues in the absence
of disease progression or unacceptable toxicity.
- Arm II: Patients receive zoledronate, vitamin D, and calcium as in arm I. Within 6
weeks of beginning study treatment, patients also receive a single dose of either
strontium chloride Sr 89 IV or samarium Sm 153 lexidronam pentasodium IV.
Quality of life and pain are assessed at baseline and then at 1, 3, 6, and 12 months from
start of protocol treatment.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 352 patients will be accrued for this study.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Time to development of a malignant skeletal-related events (SRE)
No
Michael J. Seider, MD, PhD, FACR
Study Chair
Summa Center for Cancer Care at Akron City Hospital
United States: Federal Government
CDR0000491233
NCT00365105
July 2006
Name | Location |
---|---|
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Mercy Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
Cape Cod Hospital | Hyannis, Massachusetts 02601 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
New York Methodist Hospital | Brooklyn, New York 11215-3609 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Greenville | Greenville, South Carolina 29615 |
LDS Hospital | Salt Lake City, Utah 84143 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Bellin Memorial Hospital | Green Bay, Wisconsin 54301 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Advocate Christ Medical Center | Oak Lawn, Illinois 60453 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Dickinson County Healthcare System | Iron Mountain, Michigan 49801 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
General Robert Huyser Cancer Center at David Grant Medical Center | Travis Air Force Base, California 94535 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
St. Francis Hospital | Federal Way, Washington 98003 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Cancer Center at Ball Memorial Hospital | Muncie, Indiana 47303 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Cancer Treatment Center | Wooster, Ohio 44691 |
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Truman Medical Center - Hospital Hill | Kansas City, Missouri 64108 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
York Cancer Center at Apple Hill Medical Center | York, Pennsylvania 17405 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Franciscan Cancer Center at St. Joseph Medical Center | Tacoma, Washington 98405-3004 |
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona, California 91767 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Theda Care Cancer Institute | Appleton, Wisconsin 54911 |
MedCentral - Mansfield Hospital | Mansfield, Ohio 44903 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Baptist Medical Center South | Jascksonville, Florida 32258 |
Florida Cancer Center - Palatka | Palatka, Florida 32177 |
Flagler Cancer Center | Saint Augustine, Florida 32086 |
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland, New Jersey 08360 |
Lipson Cancer and Blood Center at Rochester General Hospital | Rochester, New York 14621 |
Providence Cancer Center at Providence Hospital | Mobile, Alabama 36608 |
Trinity CancerCare Center | Minot, North Dakota 58701 |
United States Air Force Medical Center - Wright-Patterson | Wright-Patterson AFB, Ohio 45433-5529 |
Cancer Care Center, Incorporated | Salem, Ohio 44460 |
Center for Cancer Care at Goshen General Hospital | Goshen, Indiana 46526 |
UPMC Cancer Center at UPMC Presbyterian | Pittsburgh, Pennsylvania 15213 |
Bay Medical | Panama City, Florida 32401 |
Integrated Community Oncology Network - Orange Park | Orange Park, Florida 32073 |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York 12901 |
Radiation Oncology Center | Alliance, Ohio 44601 |
Central Maine Comprehensive Cancer Center at Central Maine Medical Center | Lewiston, Maine 04240 |
UPMC Cancer Center at Beaver Medical Center | Beaver, Pennsylvania 15009 |
UPMC Cancer Center at Jefferson Regional Medical Center | Clairton, Pennsylvania 15025 |
UPMC Cancer Center - Arnold Palmer Pavilion | Greensburg, Pennsylvania 15601 |
UPMC Cancer Center at the John P. Murtha Pavilion | Johnstown, Pennsylvania 15901 |
UPMC - Moon | Moon Township, Pennsylvania 15108 |
UPMC Cancer Center - Natrona Heights | Natrona Heights, Pennsylvania 15065 |
Jameson Memorial Hospital - North Campus | New Castle, Pennsylvania 16105 |
UPMC - Shadyside | Pittsburgh, Pennsylvania 15213-2582 |
UPMC Cancer Center at UPMC St. Margaret | Pittsburgh, Pennsylvania 15215 |
UPMC Cancer Center at UPMC Passavant | Pittsburgh, Pennsylvania 15237 |
UPMC Cancer Center at UPMC Northwest | Seneca, Pennsylvania 16346 |
Washington Hospital Cancer Center | Washington, Pennsylvania 15301 |
University Medical Center at Princeton | Princeton, New Jersey 08540 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
Sands Cancer Center | Canandiaqua, New York 14424 |
University Radiation Oncology at Parkridge Hospital | Rochester, New York 14626 |
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank, California 91505 |
Integrated Community Oncology Network at Southside Cancer Center | Jacksonville, Florida 32207 |
Riverview UW Cancer Center at Riverview Hospital | Wisconsin Rapids, Wisconsin 54494 |
Northeast Radiation Oncology Center | Dunmore, Pennsylvania 18512 |
New Mexico Cancer Center | Albuquerque, New Mexico 87109 |
Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital | Downers Grove, Illinois 60515-1500 |
Miami Cancer Center at Mercy Hospital | Miami, Florida 33133 |
Princeton Radiation Oncology Center | Jamesburg, New Jersey 08831 |
UPMC Cancer Center at UPMC McKeesport | McKeesport, Pennsylvania 15132 |
UPMC Cancer Center - Upper St. Clair | Pittsburgh, Pennsylvania 15243 |
UPMC Cancer Center - Uniontown | Uniontown, Pennsylvania 15401 |