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Clinical Trial Name - Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or

 
Original Study ID : CDR0000491233
Secondary ID : RTOG-0517
NCT ID : NCT00365105
Brief Title : 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
Official Title : Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer
Brief Summary :

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.

Source : National Cancer Institute (NCI)
Detailed Description :

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.

Overall Status : Recruiting
Start Date : July 2006
Official Title : Phase 3
Phase : Interventional
Study Design : Supportive Care, Randomized, Open Label
Enrollment : 352
Verification Date : May 2009
First Received Date : August 16, 2006
Trial Eligibility
Criteria :
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)

- 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)
Gender : Both
Minimum Age : 18 Years
Maximum Age : N/A
Healthy Volunteers : No
Facilities
Facility Name : Providence Cancer Center at Providence Hospital
Status : Recruiting
City : Mobile
State : Alabama
Zip Code : 36608
Country : United States
Facility Name : Mercy Cancer Center at Mercy San Juan Medical Center
Status : Recruiting
City : Carmichael
State : California
Zip Code : 95608
Country : United States
Facility Name : Providence Saint Joseph Medical Center - Burbank
Status : Recruiting
City : Burbank
State : California
Zip Code : 91505
Country : United States
Facility Name : Radiation Oncology Center - Roseville
Status : Recruiting
City : Roseville
State : California
Zip Code : 95661
Country : United States
Facility Name : Radiological Associates of Sacramento Medical Group, Incorporated
Status : Recruiting
City : Sacramento
State : California
Zip Code : 95815
Country : United States
Facility Name : Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Status : Recruiting
City : Pomona
State : California
Zip Code : 91767
Country : United States
Facility Name : USC/Norris Comprehensive Cancer Center and Hospital
Status : Recruiting
City : Los Angeles
State : California
Zip Code : 90089-9181
Country : United States
Facility Name : University of Colorado Cancer Center at UC Health Sciences Center
Status : Recruiting
City : Aurora
State : Colorado
Zip Code : 80045
Country : United States
Facility Name : Baptist Cancer Institute - Jacksonville
Status : Recruiting
City : Jacksonville
State : Florida
Zip Code : 32207
Country : United States
Facility Name : Baptist Medical Center South
Status : Recruiting
City : Jascksonville
State : Florida
Zip Code : 32258
Country : United States
Facility Name : Bay Medical
Status : Recruiting
City : Panama City
State : Florida
Zip Code : 32401
Country : United States
Facility Name : CCOP - Mount Sinai Medical Center
Status : Recruiting
City : Miami Beach
State : Florida
Zip Code : 33140
Country : United States
Facility Name : Flagler Cancer Center
Status : Recruiting
City : Saint Augustine
State : Florida
Zip Code : 32086
Country : United States
Facility Name : Florida Cancer Center - Palatka
Status : Recruiting
City : Palatka
State : Florida
Zip Code : 32177
Country : United States
Facility Name : H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Status : Recruiting
City : Tampa
State : Florida
Zip Code : 33612-9497
Country : United States
Facility Name : Integrated Community Oncology Network - Orange Park
Status : Recruiting
City : Orange Park
State : Florida
Zip Code : 32073
Country : United States
Facility Name : Integrated Community Oncology Network at Southside Cancer Center
Status : Recruiting
City : Jacksonville
State : Florida
Zip Code : 32207
Country : United States
Facility Name : Integrated Community Oncology Network
Status : Recruiting
City : Jacksonville Beach
State : Florida
Zip Code : 32250
Country : United States
Facility Name : Miami Cancer Center at Mercy Hospital
Status : Recruiting
City : Miami
State : Florida
Zip Code : 33133
Country : United States
Facility Name : Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Status : Recruiting
City : Fort Lauderdale
State : Florida
Zip Code : 33308
Country : United States
Facility Name : University of Miami Sylvester Comprehensive Cancer Center - Miami
Status : Recruiting
City : Miami
State : Florida
Zip Code : 33136
Country : United States
Facility Name : Advocate Lutheran General Cancer Care Center
Status : Recruiting
City : Park Ridge
State : Illinois
Zip Code : 60068-1174
Country : United States
Facility Name : Cancer Institute at St. John's Hospital
Status : Recruiting
City : Springfield
State : Illinois
Zip Code : 62702
Country : United States
Facility Name : CCOP - Carle Cancer Center
Status : Recruiting
City : Urbana
State : Illinois
Zip Code : 61801
Country : United States
Facility Name : John H. Stroger, Jr. Hospital of Cook County
Status : Recruiting
City : Chicago
State : Illinois
Zip Code : 60612-3785
Country : United States
Facility Name : Northwest Community Hospital
Status : Recruiting
City : Arlington Heights
State : Illinois
Zip Code : 60005
Country : United States
Facility Name : Oncology Hematology Associates of Central Illinois, PC - Peoria
Status : Recruiting
City : Peoria
State : Illinois
Zip Code : 61615
Country : United States
Facility Name : Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
Status : Recruiting
City : Olympia Fields
State : Illinois
Zip Code : 60461
Country : United States
Facility Name : Cancer Center at Ball Memorial Hospital
Status : Recruiting
City : Muncie
State : Indiana
Zip Code : 47303-3499
Country : United States
Facility Name : Center for Cancer Care at Goshen General Hospital
Status : Recruiting
City : Goshen
State : Indiana
Zip Code : 46526
Country : United States
Facility Name : CCOP - Iowa Oncology Research Association
Status : Recruiting
City : Des Moines
State : Iowa
Zip Code : 50309
Country : United States
Facility Name : John Stoddard Cancer Center at Iowa Methodist Medical Center
Status : Recruiting
City : Des Moines
State : Iowa
Zip Code : 50309
Country : United States
Facility Name : McFarland Clinic, PC
Status : Recruiting
City : Ames
State : Iowa
Zip Code : 50010
Country : United States
Facility Name : Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Status : Recruiting
City : Des Moines
State : Iowa
Zip Code : 50309
Country : United States
Facility Name : Medical Oncology and Hematology Associates at Mercy Cancer Center
Status : Recruiting
City : Des Moines
State : Iowa
Zip Code : 50314
Country : United States
Facility Name : Mercy Cancer Center at Mercy Medical Center - Des Moines
Status : Recruiting
City : Des Moines
State : Iowa
Zip Code : 50314
Country : United States
Facility Name : Siouxland Hematology-Oncology Associates, LLP
Status : Recruiting
City : Sioux City
State : Iowa
Zip Code : 51101
Country : United States
Facility Name : Tulane Cancer Center Office of Clinical Research
Status : Recruiting
City : Alexandria
State : Louisiana
Zip Code : 71315-3198
Country : United States
Facility Name : St. Agnes Hospital Cancer Center
Status : Recruiting
City : Baltimore
State : Maryland
Zip Code : 21229
Country : United States
Facility Name : Cape Cod Hospital
Status : Recruiting
City : Hyannis
State : Massachusetts
Zip Code : 02601
Country : United States
Facility Name : Bronson Methodist Hospital
Status : Recruiting
City : Kalamazoo
State : Michigan
Zip Code : 49007
Country : United States
Facility Name : Dickinson County Healthcare System
Status : Recruiting
City : Iron Mountain
State : Michigan
Zip Code : 49801
Country : United States
Facility Name : Genesys Hurley Cancer Institute
Status : Recruiting
City : Flint
State : Michigan
Zip Code : 48503
Country : United States
Facility Name : Hurley Medical Center
Status : Recruiting
City : Flint
State : Michigan
Zip Code : 48503
Country : United States
Facility Name : Josephine Ford Cancer Center at Henry Ford Hospital
Status : Recruiting
City : Detroit
State : Michigan
Zip Code : 48202
Country : United States
Facility Name : Oakwood Cancer Center at Oakwood Hospital and Medical Center
Status : Recruiting
City : Dearborn
State : Michigan
Zip Code : 48123-2500
Country : United States
Facility Name : Saint Joseph Mercy Cancer Center
Status : Recruiting
City : Ann Arbor
State : Michigan
Zip Code : 48106-0995
Country : United States
Facility Name : Sparrow Regional Cancer Center
Status : Recruiting
City : Lansing
State : Michigan
Zip Code : 48912-1811
Country : United States
Facility Name : St. John Macomb Hospital
Status : Recruiting
City : Warren
State : Michigan
Zip Code : 48093
Country : United States
Facility Name : Van Elslander Cancer Center at St. John Hospital and Medical Center
Status : Recruiting
City : Grosse Pointe Woods
State : Michigan
Zip Code : 48236
Country : United States
Facility Name : West Michigan Cancer Center
Status : Recruiting
City : Kalamazoo
State : Michigan
Zip Code : 49007-3731
Country : United States
Facility Name : CentraCare Clinic - River Campus
Status : Recruiting
City : Saint Cloud
State : Minnesota
Zip Code : 56303
Country : United States
Facility Name : Regional Cancer Center at Singing River Hospital
Status : Recruiting
City : Pascagoula
State : Mississippi
Zip Code : 39581
Country : United States
Facility Name : CCOP - Kansas City
Status : Recruiting
City : Kansas City
State : Missouri
Zip Code : 64131
Country : United States
Facility Name : Hulston Cancer Center at Cox Medical Center South
Status : Recruiting
City : Springfield
State : Missouri
Zip Code : 65807
Country : United States
Facility Name : St. John's Regional Health Center
Status : Recruiting
City : Springfield
State : Missouri
Zip Code : 65804
Country : United States
Facility Name : CCOP - Montana Cancer Consortium
Status : Recruiting
City : Billings
State : Montana
Zip Code : 59101
Country : United States
Facility Name : Great Falls Clinic - Main Facility
Status : Recruiting
City : Great Falls
State : Montana
Zip Code : 59405
Country : United States
Facility Name : Northern Rockies Radiation Oncology Center
Status : Recruiting
City : Billings
State : Montana
Zip Code : 59101
Country : United States
Facility Name : Good Samaritan Cancer Center at Good Samaritan Hospital
Status : Recruiting
City : Kearney
State : Nebraska
Zip Code : 68848-1990
Country : United States
Facility Name : Cancer Institute of New Jersey at Cooper University Hospital - Camden
Status : Recruiting
City : Camden
State : New Jersey
Zip Code : 08103
Country : United States
Facility Name : Cancer Institute of New Jersey at Cooper - Voorhees
Status : Recruiting
City : Voorhees
State : New Jersey
Zip Code : 08043
Country : United States
Facility Name : Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Status : Recruiting
City : Marlton
State : New Jersey
Zip Code : 08053
Country : United States
Facility Name : Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Status : Recruiting
City : Vineland
State : New Jersey
Zip Code : 08360
Country : United States
Facility Name : University Medical Center at Princeton
Status : Recruiting
City : Princeton
State : New Jersey
Zip Code : 08540-3298
Country : United States
Facility Name : New Mexico Cancer Center
Status : Recruiting
City : Albuquerque
State : New Mexico
Zip Code : 87109
Country : United States
Facility Name : James P. Wilmot Cancer Center at University of Rochester Medical Center
Status : Recruiting
City : Rochester
State : New York
Zip Code : 14642
Country : United States
Facility Name : New York Methodist Hospital
Status : Recruiting
City : Brooklyn
State : New York
Zip Code : 11215
Country : United States
Facility Name : Mission Hospitals - Memorial Campus
Status : Recruiting
City : Asheville
State : North Carolina
Zip Code : 28801
Country : United States
Facility Name : Presbyterian Cancer Center at Presbyterian Hospital
Status : Recruiting
City : Charlotte
State : North Carolina
Zip Code : 28233-3549
Country : United States
Facility Name : Wayne Radiation Oncology
Status : Recruiting
City : Goldsboro
State : North Carolina
Zip Code : 27534
Country : United States
Facility Name : Trinity CancerCare Center
Status : Recruiting
City : Minot
State : North Dakota
Zip Code : 58701
Country : United States
Facility Name : Barberton Citizens Hospital
Status : Recruiting
City : Barberton
State : Ohio
Zip Code : 44203
Country : United States
Facility Name : Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Status : Recruiting
City : Salem
State : Ohio
Zip Code : 44460
Country : United States
Facility Name : Cancer Treatment Center
Status : Recruiting
City : Wooster
State : Ohio
Zip Code : 44691
Country : United States
Facility Name : CCOP - Dayton
Status : Recruiting
City : Dayton
State : Ohio
Zip Code : 45429
Country : United States
Facility Name : Charles F. Kettering Memorial Hospital
Status : Recruiting
City : Kettering
State : Ohio
Zip Code : 45429
Country : United States
Facility Name : David L. Rike Cancer Center at Miami Valley Hospital
Status : Recruiting
City : Dayton
State : Ohio
Zip Code : 45409
Country : United States
Facility Name : Good Samaritan Hospital
Status : Recruiting
City : Dayton
State : Ohio
Zip Code : 45406
Country : United States
Facility Name : Grandview Hospital
Status : Recruiting
City : Dayton
State : Ohio
Zip Code : 45405
Country : United States
Facility Name : McDowell Cancer Center at Akron General Medical Center
Status : Recruiting
City : Akron
State : Ohio
Zip Code : 44307
Country : United States
Facility Name : MedCentral - Mansfield Hospital
Status : Recruiting
City : Mansfield
State : Ohio
Zip Code : 44903
Country : United States
Facility Name : Mercy Cancer Center at Mercy Medical Center
Status : Recruiting
City : Canton
State : Ohio
Zip Code : 44708
Country : United States
Facility Name : Middletown Regional Hospital
Status : Recruiting
City : Franklin
State : Ohio
Zip Code : 45005-1066
Country : United States
Facility Name : Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Status : Recruiting
City : Xenia
State : Ohio
Zip Code : 45385
Country : United States
Facility Name : Samaritan North Cancer Care Center
Status : Recruiting
City : Dayton
State : Ohio
Zip Code : 45415
Country : United States
Facility Name : Summa Center for Cancer Care at Akron City Hospital
Status : Recruiting
City : Akron
State : Ohio
Zip Code : 44309-2090
Country : United States
Facility Name : UVMC Cancer Care Center at Upper Valley Medical Center
Status : Recruiting
City : Troy
State : Ohio
Zip Code : 45373-1300
Country : United States
Facility Name : Mount Nittany Medical Center
Status : Recruiting
City : State College
State : Pennsylvania
Zip Code : 16803
Country : United States
Facility Name : Northeast Radiation Oncology Center
Status : Recruiting
City : Dunmore
State : Pennsylvania
Zip Code : 18512
Country : United States
Facility Name : Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Status : Recruiting
City : Pittsburgh
State : Pennsylvania
Zip Code : 15224-1791
Country : United States
Facility Name : York Cancer Center at Apple Hill Medical Center
Status : Recruiting
City : York
State : Pennsylvania
Zip Code : 17405
Country : United States
Facility Name : Hollings Cancer Center at Medical University of South Carolina
Status : Recruiting
City : Charleston
State : South Carolina
Zip Code : 29425
Country : United States
Facility Name : Dixie Regional Medical Center - East Campus
Status : Recruiting
City : Saint George
State : Utah
Zip Code : 84770
Country : United States
Facility Name : Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Status : Recruiting
City : Murray
State : Utah
Zip Code : 84157
Country : United States
Facility Name : LDS Hospital
Status : Recruiting
City : Salt Lake City
State : Utah
Zip Code : 84143
Country : United States
Facility Name : Utah Cancer Specialists at UCS Cancer Center
Status : Recruiting
City : Salt Lake City
State : Utah
Zip Code : 84106
Country : United States
Facility Name : North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Status : Recruiting
City : Yakima
State : Washington
Zip Code : 98902
Country : United States
Facility Name : Gundersen Lutheran Center for Cancer and Blood
Status : Recruiting
City : La Crosse
State : Wisconsin
Zip Code : 54601
Country : United States
Facility Name : Theda Care Cancer Institute
Status : Recruiting
City : Appleton
State : Wisconsin
Zip Code : 54911
Country : United States
OutComes
Primary OutComes
Measure : Time to development of a malignant skeletal-related events (SRE)
Safety issue : No
Secondary OutComes
Measure : SRE rate at 1 year
Safety issue : No
Measure : Overall survival
Safety issue : No
Measure : Changes in quality of life as measured by FACT-G
Safety issue : No
Measure : Changes in pain control as measured by Brief Pain Inventory (BPI)
Safety issue : No
Measure : Utility and cost effectiveness of the use of radiopharmaceuticals and bisphosphonates as measured by the EuroQol-5 Dimension (EQ-5D)
Safety issue : No
Interventions
Type : Dietary Supplement
Name : calcium carbonate
Description : Zoledronic acid given IV; vitamin D and calcium given orally
Type : Dietary Supplement
Name : calcium citrate
Description : Zoledronic acid given IV; vitamin D and calcium given orally
Type : Dietary Supplement
Name : calcium glucarate
Description : Zoledronic acid given IV; vitamin D and calcium given orally
Type : Dietary Supplement
Name : vitamin D
Description : Zoledronic acid given IV; vitamin D and calcium given orally
Type : Drug
Name : calcium gluconate
Description : Zoledronic acid given IV; vitamin D and calcium given orally
Type : Drug
Name : zoledronic acid
Description : Zoledronic acid given IV; vitamin D and calcium given orally
Type : Radiation
Name : samarium Sm 153 lexidronam pentasodium
Description : Given IV
Type : Radiation
Name : strontium chloride Sr 89
Description : Given IV
 
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