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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Lung Cancer, Metastatic Cancer, Pain, Prostate Cancer

Thank you

Trial Information

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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Time to development of a malignant skeletal-related events (SRE)

Safety Issue:

No

Principal Investigator

Michael J. Seider, MD, PhD, FACR

Investigator Role:

Study Chair

Investigator Affiliation:

Summa Center for Cancer Care at Akron City Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000491233

NCT ID:

NCT00365105

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Metastatic Cancer
  • Pain
  • Prostate Cancer
  • pain
  • bone metastases
  • extensive stage small cell lung cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Breast Neoplasms
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms

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