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 |
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.
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.
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
Click here to add this to my saved trials
1200 Old York Road
Abington, Pennsylvania 19001
Abington, Pennsylvania 19001
(215) 481-2400
Rosenfeld Cancer Center at Abington Memorial Hospital As one of the most trusted cancer centers...
Click here to add this to my saved trials
86 Jonathan Lucas Street
Charleston, South Carolina 29425
Charleston, South Carolina 29425
(843) 792-0700
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
Click here to add this to my saved trials
200 Hawthorne Lane
Charlotte, North Carolina 28233
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
Click here to add this to my saved trials
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
Click here to add this to my saved trials
4725 North Federal Highway
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
(954) 492-5764
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Holy Cross Hospital's Michael...
Click here to add this to my saved trials
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
Click here to add this to my saved trials
19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
Click here to add this to my saved trials
Click here to add this to my saved trials
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
Click here to add this to my saved trials
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
Click here to add this to my saved trials
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
Click here to add this to my saved trials
Click here to add this to my saved trials
1717 S J St
Tacoma, Washington 98405
Tacoma, Washington 98405
(253) 426-4101
Franciscan Cancer Center at St. Joseph Medical Center St. Joseph Medical Center is a 361-bed...
Click here to add this to my saved trials
4117 East Fowler Avenue
Tampa, Florida 33612
Tampa, Florida 33612
(813) 745-4673
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Moffitt Cancer...
Click here to add this to my saved trials
42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
Click here to add this to my saved trials
Click here to add this to my saved trials
1 Akron General Ave
Akron, Ohio 44307
Akron, Ohio 44307
(330) 344-6000
McDowell Cancer Center at Akron General Medical Center Learning that you or someone you love...
Click here to add this to my saved trials
161 North Forge Street
Akron, Ohio 44304
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
Click here to add this to my saved trials
Click here to add this to my saved trials
1415 Tulane Ave., HC-62
Alexandria, Louisiana 70112
Alexandria, Louisiana 70112
504-988-6121
Tulane Cancer Center Office of Clinical Research As an academic cancer center, Tulane offers our...
Click here to add this to my saved trials
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
Click here to add this to my saved trials
Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
St. Agnes Hospital Cancer Center Saint Agnes Hospital is leading Maryland in the battle against...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
Click here to add this to my saved trials
Burbank, California 91505
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
Click here to add this to my saved trials
Click here to add this to my saved trials
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
Click here to add this to my saved trials
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
Click here to add this to my saved trials
Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
Click here to add this to my saved trials
18101 Oakwood Blvd
Dearborn, Michigan 48124
Dearborn, Michigan 48124
(313) 593-8620
Oakwood Cancer Center at Oakwood Hospital and Medical Center In today's health care environment, a...
Click here to add this to my saved trials
300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
Click here to add this to my saved trials
1221 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-4141
John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
Click here to add this to my saved trials
1221 Pleasant St Suite 100
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 282-2921
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
Click here to add this to my saved trials
411 Laurel St New Visions
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3970
Medical Oncology and Hematology Associates at Mercy Cancer Center When it comes to cancer care,...
Click here to add this to my saved trials
411 Laurel Street
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3121
Mercy Cancer Center at Mercy Medical Center - Des Moines When it comes to cancer...
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
Detroit, Michigan 48202
(888) 777-4167
Josephine Ford Cancer Center at Henry Ford Hospital A diagnosis of cancer is one of...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
St. Francis Hospital St. Francis Hospital, conveniently located near the center of Federal Way, serves...
Click here to add this to my saved trials
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
Click here to add this to my saved trials
Click here to add this to my saved trials
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
One Ingalls Drive
Harvey, Illinois 60426
Harvey, Illinois 60426
708.333.2300
Ingalls Cancer Care Center at Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1721 S Stephenson Ave
Iron Mountain, Michigan 49801
Iron Mountain, Michigan 49801
(906) 774-1313
Dickinson County Healthcare System The vision of Dickinson County Healthcare System is to provide quality...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
800 Prudential Drive
Jacksonville, Florida 32207
Jacksonville, Florida 32207
904.202.2000
Baptist Cancer Institute - Jacksonville For more than 20 years, health care consumers have named...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Sparrow Regional Cancer Center Sparrow has grown to become the region's largest health system, and...
Click here to add this to my saved trials
Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
Click here to add this to my saved trials
Click here to add this to my saved trials
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
90 Brick Rd
Marlton, New Jersey 08053
Marlton, New Jersey 08053
(856) 355-6000
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Virtua collaborates with Fox...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
5121 South Cottonwood Street
Murray, Utah 84157
Murray, Utah 84157
(801) 507-3800
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center The Jon and Karen Huntsman...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Advocate Christ Medical Center Advocate Health Care, named among the nation
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
2809 Denny Ave
Pascagoula, Mississippi 39581
Pascagoula, Mississippi 39581
228-809-5251
Regional Cancer Center at Singing River Hospital The Regional Cancer Center team at Singing River...
Click here to add this to my saved trials