Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer



Status:Completed
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Chronic Pain
Therapuetic Areas:Musculoskeletal, Oncology
Healthy:No
Age Range:18 - Any
Updated:5/5/2018
Start Date:July 11, 2006
End Date:February 27, 2017

Use our guide to learn which trials are right for you!

Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer

RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other
symptoms caused by bone metastases. It is not yet known whether giving zoledronate together
with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in
treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer.

PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to
see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89
or samarium 153 in preventing or delaying bone problems in patients with bone metastases from
prostate cancer, lung cancer, or breast 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.

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed lung, breast, or prostate cancer

- Bone metastases, meeting both of the following criteria:

- Must be visible on bone scan performed within the past 4 weeks

- No painful bone metastases unless successfully treated (i.e., by external-beam
irradiation) prior to study entry AND the patient has stable pain* for at least 2
weeks after that treatment NOTE: *Stable pain is defined as a patient response of
1, 2, or 3 on Questions 4 and 5 of The Brief Pain Inventory (BPI)

- No untreated or symptomatic brain metastases

- No spinal cord compression

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Zubrod performance status (PS) 0-2 (for patients with primary breast or prostate
cancer) OR Zubrod PS 0-1 (for patients with primary lung cancer)

- White blood cell count (WBC) ≥ 2,400/mm³

- Absolute neutrophil count ≥ 1,800/mm³

- Platelet count ≥ 60,000/mm³

- Hemoglobin ≥ 8.0 g/dL (transfusion allowed)

- Creatinine < 3.0 mg/dL

- Bilirubin < 2.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled congestive heart failure within the past 6 months

- No hypertension refractory to treatment within the past 6 months

- No symptomatic coronary artery disease within the past 6 months

- No current, active dental problems within the past 4 weeks, including any of the
following:

- Infection of the teeth or jawbone (maxilla or mandible)

- Dental or fixture trauma

- Prior or current diagnosis of osteonecrosis of the jaw

- Exposed bone in the mouth

- Slow healing after dental procedures

- No known AIDS

- HIV testing is not required

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Prior oral bisphosphonate therapy (i.e. alendronate sodium or similar) allowed

- No prior IV bisphosphonates for a treatment duration of > 6 months

- At least 2 weeks since prior calcitonin, mithramycin, or gallium nitrate

- At least 2 weeks since prior external-beam radiotherapy

- At least 6 weeks since prior and no concurrent dental surgery (e.g., extractions or
implants)

- No prior radioisotope therapy for bone metastasis

- Concurrent systemic chemotherapy* or hormonal therapy allowed

- Chemotherapy and/or hormonal therapy should not be changed within 14 days prior
to start of protocol treatment (arm I)

- No other concurrent bisphosphonate NOTE: *Chemotherapy must be held 2 weeks before and
for at least 2 weeks after radiopharmaceutical administration (arm II)
We found this trial at
147
sites
Natrona Heights, Pennsylvania 15065
?
mi
from
Natrona Heights, PA
Click here to add this to my saved trials
1200 Old York Road
Abington, Pennsylvania 19001
(215) 481-2400
Rosenfeld Cancer Center at Abington Memorial Hospital As one of the most trusted cancer centers...
?
mi
from
Abington, PA
Click here to add this to my saved trials
86 Jonathan Lucas Street
Charleston, South Carolina 29425
(843) 792-0700
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
200 Hawthorne Lane
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
?
mi
from
Flint, MI
Click here to add this to my saved trials
4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 492-5764
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Holy Cross Hospital's Michael...
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
?
mi
from
Greenville, SC
Click here to add this to my saved trials
19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
?
mi
from
Grosse Pointe Woods, MI
Click here to add this to my saved trials
9143 Philips Hwy # 560
Jacksonville Beach, Florida 32250
?
mi
from
Jacksonville Beach, FL
Click here to add this to my saved trials
200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
600 Zeagler Drive
Palatka, Florida 32177
?
mi
from
Palatka, FL
Click here to add this to my saved trials
Panama City, Florida 32401
?
mi
from
Panama City, FL
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
300 Health Park Blvd # 1008
Saint Augustine, Florida 32086
?
mi
from
Saint Augustine, FL
Click here to add this to my saved trials
1717 S J St
Tacoma, Washington 98405
(253) 426-4101
Franciscan Cancer Center at St. Joseph Medical Center St. Joseph Medical Center is a 361-bed...
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
4117 East Fowler Avenue
Tampa, Florida 33612
(813) 745-4673
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Moffitt Cancer...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
808 North 39th Avenue
Yakima, Washington 98902
?
mi
from
Yakima, WA
Click here to add this to my saved trials
1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
McDowell Cancer Center at Akron General Medical Center Learning that you or someone you love...
?
mi
from
Akron, OH
Click here to add this to my saved trials
161 North Forge Street
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1415 Tulane Ave., HC-62
Alexandria, Louisiana 70112
504-988-6121
Tulane Cancer Center Office of Clinical Research As an academic cancer center, Tulane offers our...
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
Alliance, Ohio 44601
?
mi
from
Alliance, OH
Click here to add this to my saved trials
Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
?
mi
from
Ames, IA
Click here to add this to my saved trials
5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-4673
Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Appleton, Wisconsin 54911
?
mi
from
Appleton, WI
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
900 Caton Ave.
Baltimore, Maryland 21229
410-368-6000
St. Agnes Hospital Cancer Center Saint Agnes Hospital is leading Maryland in the battle against...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Barberton, Ohio 44203
?
mi
from
Barberton, OH
Click here to add this to my saved trials
Beaver, Pennsylvania 15009
?
mi
from
Beaver, PA
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59107
?
mi
from
Billings, MT
Click here to add this to my saved trials
506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Burbank, CA
Click here to add this to my saved trials
360 Parrish Street
Canandaigua, New York 14424
?
mi
from
Canandaigua, NY
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
?
mi
from
Chillicothe, OH
Click here to add this to my saved trials
?
mi
from
Clairton, PA
Click here to add this to my saved trials
1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
?
mi
from
Columbus, GA
Click here to add this to my saved trials
1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dayton, Ohio 45406
?
mi
from
Dayton, OH
Click here to add this to my saved trials
1 Wyoming St
Dayton, Ohio 45409
(937) 208-2300
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45420
?
mi
from
Dayton, OH
Click here to add this to my saved trials
405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
9000 North Main Street
Dayton, Ohio 45415
(937) 734-5800
Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
18101 Oakwood Blvd
Dearborn, Michigan 48124
(313) 593-8620
Oakwood Cancer Center at Oakwood Hospital and Medical Center In today's health care environment, a...
?
mi
from
Dearborn, MI
Click here to add this to my saved trials
300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
1221 Pleasant St
Des Moines, Iowa 50309
(515) 241-4141
John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
1221 Pleasant St Suite 100
Des Moines, Iowa 50309
(515) 282-2921
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
411 Laurel St New Visions
Des Moines, Iowa 50314
(515) 247-3970
Medical Oncology and Hematology Associates at Mercy Cancer Center When it comes to cancer care,...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
411 Laurel Street
Des Moines, Iowa 50314
(515) 247-3121
Mercy Cancer Center at Mercy Medical Center - Des Moines When it comes to cancer...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(888) 777-4167
Josephine Ford Cancer Center at Henry Ford Hospital A diagnosis of cancer is one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Downers Grove, IL
Click here to add this to my saved trials
Dunmore, Pennsylvania 18512
?
mi
from
Dunmore, PA
Click here to add this to my saved trials
?
mi
from
Fall River, MA
Click here to add this to my saved trials
34515 Ninth Ave. S.
Federal Way, Washington 98003
(253) 944-8100
St. Francis Hospital St. Francis Hospital, conveniently located near the center of Federal Way, serves...
?
mi
from
Federal Way, WA
Click here to add this to my saved trials
302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
?
mi
from
Flint, MI
Click here to add this to my saved trials
105 Mcknight Drive
Franklin, Ohio 45005
513-424-2111
?
mi
from
Franklin, OH
Click here to add this to my saved trials
743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
Goldsboro, North Carolina 27534
?
mi
from
Goldsboro, NC
Click here to add this to my saved trials
?
mi
from
Goshen, IN
Click here to add this to my saved trials
Great Falls, Montana 59405
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
Green Bay, Wisconsin 54301
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
Greensburg, Pennsylvania 15601
?
mi
from
Greensburg, PA
Click here to add this to my saved trials
One Ingalls Drive
Harvey, Illinois 60426
708.333.2300
Ingalls Cancer Care Center at Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare...
?
mi
from
Harvey, IL
Click here to add this to my saved trials
?
mi
from
Hines, IL
Click here to add this to my saved trials
Hyannis, Massachusetts 02601
?
mi
from
Hyannis, MA
Click here to add this to my saved trials
1721 S Stephenson Ave
Iron Mountain, Michigan 49801
(906) 774-1313
Dickinson County Healthcare System The vision of Dickinson County Healthcare System is to provide quality...
?
mi
from
Iron Mountain, MI
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jacksonville, Florida 32258
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
800 Prudential Drive
Jacksonville, Florida 32207
904.202.2000
Baptist Cancer Institute - Jacksonville For more than 20 years, health care consumers have named...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jamesburg, New Jersey 08831
?
mi
from
Jamesburg, NJ
Click here to add this to my saved trials
?
mi
from
Johnstown, PA
Click here to add this to my saved trials
Kansas City, Missouri 64108
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kansas City, Missouri 64131
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Kearney, NE
Click here to add this to my saved trials
?
mi
from
Kettering, OH
Click here to add this to my saved trials
1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-2890
Sparrow Regional Cancer Center Sparrow has grown to become the region's largest health system, and...
?
mi
from
Lansing, MI
Click here to add this to my saved trials
325 Maine Street
Lawrence, Kansas 66044
(785) 505-5000
Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
?
mi
from
Lawrence, KS
Click here to add this to my saved trials
?
mi
from
Lewiston, ME
Click here to add this to my saved trials
1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Mansfield, Ohio 44903
?
mi
from
Mansfield, OH
Click here to add this to my saved trials
90 Brick Rd
Marlton, New Jersey 08053
(856) 355-6000
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Virtua collaborates with Fox...
?
mi
from
Marlton, NJ
Click here to add this to my saved trials
McKeesport, Pennsylvania 15132
?
mi
from
McKeesport, PA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Minot, North Dakota 58701
?
mi
from
Minot, ND
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
1600 Coraopolis Heights Road
Moon, Pennsylvania 15108
?
mi
from
Moon, PA
Click here to add this to my saved trials
?
mi
from
Muncie, IN
Click here to add this to my saved trials
5121 South Cottonwood Street
Murray, Utah 84157
(801) 507-3800
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center The Jon and Karen Huntsman...
?
mi
from
Murray, UT
Click here to add this to my saved trials
New Castle, Pennsylvania 16105
?
mi
from
New Castle, PA
Click here to add this to my saved trials
4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Advocate Christ Medical Center Advocate Health Care, named among the nation
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
?
mi
from
Orange Park, FL
Click here to add this to my saved trials
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
2809 Denny Ave
Pascagoula, Mississippi 39581
228-809-5251
Regional Cancer Center at Singing River Hospital The Regional Cancer Center team at Singing River...
?
mi
from
Pascagoula, MS
Click here to add this to my saved trials