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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 - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Northwest Community HospitalArlington Heights, Illinois  60005
Cape Cod HospitalHyannis, Massachusetts  02601
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
New York Methodist HospitalBrooklyn, New York  11215-3609
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
LDS HospitalSalt Lake City, Utah  84143
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Bellin Memorial HospitalGreen Bay, Wisconsin  54301
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Central Baptist HospitalLexington, Kentucky  40503
Advocate Christ Medical CenterOak Lawn, Illinois  60453
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
Mount Nittany Medical CenterState College, Pennsylvania  16803
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Adena Regional Medical CenterChillicothe, Ohio  54601
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois  60068-1174
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
General Robert Huyser Cancer Center at David Grant Medical CenterTravis Air Force Base, California  94535
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Highland Hospital of RochesterRochester, New York  14620
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Washington  98902
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
St. Francis HospitalFederal Way, Washington  98003
Good Samaritan Cancer CenterPuyallup, Washington  98371
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Northeast Georgia Medical CenterGainesville, Georgia  30501
Cancer Center at Ball Memorial HospitalMuncie, Indiana  47303
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Cancer Treatment CenterWooster, Ohio  44691
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
John B. Amos Cancer CenterColumbus, Georgia  31904
McFarland Clinic, PCAmes, Iowa  50010
Lawrence Memorial HospitalLawrence, Kansas  66044
Truman Medical Center - Hospital HillKansas City, Missouri  64108
Billings Clinic - DowntownBillings, Montana  59107-7000
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical CenterPomona, California  91767
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Theda Care Cancer InstituteAppleton, Wisconsin  54911
MedCentral - Mansfield HospitalMansfield, Ohio  44903
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Baptist Medical Center SouthJascksonville, Florida  32258
Florida Cancer Center - PalatkaPalatka, Florida  32177
Flagler Cancer CenterSaint Augustine, Florida  32086
Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVineland, New Jersey  08360
Lipson Cancer and Blood Center at Rochester General HospitalRochester, New York  14621
Providence Cancer Center at Providence HospitalMobile, Alabama  36608
Trinity CancerCare CenterMinot, North Dakota  58701
United States Air Force Medical Center - Wright-PattersonWright-Patterson AFB, Ohio  45433-5529
Cancer Care Center, IncorporatedSalem, Ohio  44460
Center for Cancer Care at Goshen General HospitalGoshen, Indiana  46526
UPMC Cancer Center at UPMC PresbyterianPittsburgh, Pennsylvania  15213
Bay MedicalPanama City, Florida  32401
Integrated Community Oncology Network - Orange ParkOrange Park, Florida  32073
Hudner Oncology Center at Saint Anne's Hospital - Fall RiverFall River, Massachusetts  02721
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical CenterPlattsburgh, New York  12901
Radiation Oncology CenterAlliance, Ohio  44601
Central Maine Comprehensive Cancer Center at Central Maine Medical CenterLewiston, Maine  04240
UPMC Cancer Center at Beaver Medical CenterBeaver, Pennsylvania  15009
UPMC Cancer Center at Jefferson Regional Medical CenterClairton, Pennsylvania  15025
UPMC Cancer Center - Arnold Palmer PavilionGreensburg, Pennsylvania  15601
UPMC Cancer Center at the John P. Murtha PavilionJohnstown, Pennsylvania  15901
UPMC - MoonMoon Township, Pennsylvania  15108
UPMC Cancer Center - Natrona HeightsNatrona Heights, Pennsylvania  15065
Jameson Memorial Hospital - North CampusNew Castle, Pennsylvania  16105
UPMC - ShadysidePittsburgh, Pennsylvania  15213-2582
UPMC Cancer Center at UPMC St. MargaretPittsburgh, Pennsylvania  15215
UPMC Cancer Center at UPMC PassavantPittsburgh, Pennsylvania  15237
UPMC Cancer Center at UPMC NorthwestSeneca, Pennsylvania  16346
Washington Hospital Cancer CenterWashington, Pennsylvania  15301
University Medical Center at PrincetonPrinceton, New Jersey  08540
Radiation Oncology Center - RosevilleRoseville, California  95661
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
St. Agnes Hospital Cancer CenterBaltimore, Maryland  21229
Sands Cancer CenterCanandiaqua, New York  14424
University Radiation Oncology at Parkridge HospitalRochester, New York  14626
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California  91505
Integrated Community Oncology Network at Southside Cancer CenterJacksonville, Florida  32207
Riverview UW Cancer Center at Riverview HospitalWisconsin Rapids, Wisconsin  54494
Northeast Radiation Oncology CenterDunmore, Pennsylvania  18512
New Mexico Cancer CenterAlbuquerque, New Mexico  87109
Good Samaritan Cancer Care Center at Advocate Good Samaritan HospitalDowners Grove, Illinois  60515-1500
Miami Cancer Center at Mercy HospitalMiami, Florida  33133
Princeton Radiation Oncology CenterJamesburg, New Jersey  08831
UPMC Cancer Center at UPMC McKeesportMcKeesport, Pennsylvania  15132
UPMC Cancer Center - Upper St. ClairPittsburgh, Pennsylvania  15243
UPMC Cancer Center - UniontownUniontown, Pennsylvania  15401