Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate 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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Active 18 and over NCI RTOG-0517 RTOG 0517, RTOG-0517, NCT00365105

Objectives

Primary

1. 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

1. Compare the rate of SREs at 1 year in patients treated with these regimens.
2. Compare overall survival of patients treated with these regimens.
3. Compare quality of life of patients treated with these regimens.
4. Compare the effect of these regimens on pain control in these patients.
5. Evaluate resource utilization and cost effectiveness of these regimens.

Entry 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

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
• No other concurrent bisphosphonate

 [Note: *Chemotherapy must be held 2 weeks before and for at least 2 weeks after radiopharmaceutical administration (arm II)]

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

Expected Enrollment

A total of 352 patients will be accrued for this study.

Outcomes

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

SRE rate at 1 year
Overall survival
Changes in quality of life as measured by FACT-G
Changes in pain control as measured by Brief Pain Inventory (BPI)
Utility and cost effectiveness of the use of radiopharmaceuticals and bisphosphonates as measured by the EuroQol-5 Dimension (EQ-5D)

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.

After completion of study treatment, patients are followed every 6 months.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Michael Seider, MD, PhD, FACR, Protocol chair		Ph: 330-375-3557 Email: seiderm@summa-health.org

U.S.A.
California
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Carmichael
	Mercy Cancer Center at Mercy San Juan Medical Center
		Christopher Jones, MD	Ph:  916-904-3440
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451
	Pomona
	Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
		Clinical Trials Office - Robert and Beverly Lewis Family Cancer Care Center	Ph:  909-865-9555
	Roseville
	Radiation Oncology Center - Roseville
		Christopher Jones, MD	Ph:  916-969-4422
	Sacramento
	Radiological Associates of Sacramento Medical Group, Incorporated
		Christopher Jones, MD	Ph:  916-646-8300
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center	Ph:  954-776-3239
	Jacksonville
	Baptist Cancer Institute - Jacksonville
		Clinical Trials Office - Baptist Cancer Institute - Jacksonville	Ph:  904-202-7051
	Integrated Community Oncology Network at Southside Cancer Center
		Douglas Johnson, MD	Ph:  904-202-7020
	Jacksonville Beach
	Integrated Community Oncology Network
		Douglas Johnson, MD	Ph:  904-202-7020
	Jascksonville
	Baptist Medical Center South
		Douglas Johnson, MD	Ph:  904-202-7020
	Miami
	Miami Cancer Center at Mercy Hospital
		David Huang	Ph:  305-854-4400 ext. 2476
	Orange Park
	Integrated Community Oncology Network - Orange Park
		Douglas Johnson, MD	Ph:  904-202-7020
	Palatka
	Florida Cancer Center - Palatka
		Douglas Johnson, MD	Ph:  904-202-7020
	Saint Augustine
	Flagler Cancer Center
		Douglas Johnson, MD	Ph:  904-202-7020
Georgia
	Gainesville
	Northeast Georgia Medical Center
		Frank Lake, MD	Ph:  770-535-3393
Illinois
	Arlington Heights
	Northwest Community Hospital
		Stephen Nigh, MD	Ph:  847-618-6560
	Chicago
	John H. Stroger, Jr. Hospital of Cook County
		Nathanial Holloway	Ph:  312-864-3200
	Olympia Fields
	Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
		Clinical Trials Office - Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields	Ph:  708-679-2217
	Peoria
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3000
	Springfield
	Cancer Institute at St. John's Hospital
		Bruce Shevlin, MD	Ph:  217-525-5666 800-524-0575
	Urbana
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
Indiana
	Goshen
	Center for Cancer Care at Goshen General Hospital
		Clinical Trials Office - Center for Cancer Care at Goshen General Hospital	Ph:  574-535-2858
Maryland
	Baltimore
	St. Agnes Hospital Cancer Center
		Richard Hudes, MD	Ph:  410-368-2910
Massachusetts
	Hyannis
	Cape Cod Hospital
		Daniel Canaday	Ph:  508-771-1800
Michigan
	Ann Arbor
	Saint Joseph Mercy Cancer Center
		Salam Jafar, MD	Ph:  734-712-3596
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center	Ph:  313-593-8090
	Detroit
	Josephine Ford Cancer Center at Henry Ford Hospital
		Eleanor Walker, MD	Ph:  313-916-1850 888-734-5322
	Flint
	Genesys Hurley Cancer Institute
		Clinical Trials Office - Genesys Hurley Cancer Institute	Ph:  810-762-8057
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Iron Mountain
	Dickinson County Healthcare System
		Nelson Adamson	Ph:  906-774-1313
	Kalamazoo
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7488
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Lansing
	Sparrow Regional Cancer Center
		Clinical Trials Office - Sparrow Regional Cancer Center	Ph:  517-364-2890
	Warren
	St. John Macomb Hospital
		Salam Jafar, MD	Ph:  734-712-3596
Minnesota
	Saint Cloud
	CentraCare Clinic - River Campus
		Barbi Kaplan-Frenkel, DO	Ph:  320-252-5131
Mississippi
	Pascagoula
	Regional Cancer Center at Singing River Hospital
		James Clarkson, MD	Ph:  228-809-5251
Missouri
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
	Springfield
	Hulston Cancer Center at Cox Medical Center South
		John Goodwin, MD	Ph:  417-889-8099
	St. John's Regional Health Center
		John Goodwin, MD	Ph:  417-889-8099
Montana
	Billings
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-259-2245 800-361-3239
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-248-2212 800-358-8818
	Great Falls
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-454-2171 800-421-1649
New Jersey
	Camden
	Cancer Institute of New Jersey at Cooper University Hospital - Camden
		Clinical Trial Office - Cancer Institute of New Jersey at Cooper Uniersity Hospital	Ph:  856-325-6757
	Vineland
	Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
		Clinical Trials Office - Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare	Ph:  856-641-7933
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New Mexico
	Albuquerque
	New Mexico Cancer Center
		Gregg Franklin	Ph:  505-842-8171
New York
	Brooklyn
	New York Methodist Hospital
		Sameer Rafla-Demetrious, MD, PhD, FRCR, FACR, FRSM	Ph:  718-780-3677
North Carolina
	Asheville
	Mission Hospitals - Memorial Campus
		Clinical Trials Office - Mission Hospitals - Memorial Campus	Ph:  828-213-4150
	Charlotte
	Presbyterian Cancer Center at Presbyterian Hospital
		Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital	Ph:  704-384-5369
North Dakota
	Minot
	Trinity CancerCare Center
		Kevin Collins, MD	Ph:  701-857-3535
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Mitchell Fromm, MD	Ph:  330-344-6448
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph:  330-375-6101
	Mansfield
	MedCentral - Mansfield Hospital
		Clinical Trials Office - MedCentral - Mansfield Hospital	Ph:  419-526-8938
	Salem
	Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
		William Demas, MD	Ph:  330-375-3557
	Wooster
	Cancer Treatment Center
		Clinical Trials Office - Cancer Treatment Center	Ph:  330-375-4221
Pennsylvania
	Beaver
	UPMC Cancer Center at Beaver Medical Center
		Susan (Maffey) Rakfal	Ph:  724-773-7616
	Clairton
	UPMC Cancer Center at Jefferson Regional Medical Center
		Susan (Maffey) Rakfal	Ph:  412-469-5500
	Greensburg
	UPMC Cancer Center - Arnold Palmer Pavilion
		Susan (Maffey) Rakfal	Ph:  724-838-1900 800-533-8762
	Johnstown
	UPMC Cancer Center at the John P. Murtha Pavilion
		Susan (Maffey) Rakfal	Ph:  814-534-4724
	McKeesport
	UPMC Cancer Center at UPMC McKeesport
		Clinical Trials Office - UPMC Cancer Center at UPMC McKeesport	Ph:  412-647-8073
	Moon Township
	UPMC - Moon
		Susan (Maffey) Rakfal	Ph:  412-604-2020
	Natrona Heights
	UPMC Cancer Center - Natrona Heights
		Susan (Maffey) Rakfal	Ph:  724-230-3030
	New Castle
	Jameson Memorial Hospital - North Campus
		Susan (Maffey) Rakfal	Ph:  724-658-9001
	Pittsburgh
	Mercy Cancer Institute at Mercy Hospital
		Susan (Maffey) Rakfal	Ph:  412-232-7185
	UPMC - Shadyside
		Clinical Trials Office - UPMC - Shadyside	Ph:  412-621-2334
	UPMC Cancer Center - Upper St. Clair
		Susan (Maffey) Rakfal	Ph:  412-831-1320
	UPMC Cancer Center at Magee-Womens Hospital
		Clinical Trials Office - UPMC Cancer Center at Magee-Womens Hospital	Ph:  412-647-2811
	UPMC Cancer Center at UPMC Passavant
		Clinical Trials Office - UPMC Cancer Center at UPMC Passavant	Ph:  412-367-6454
	UPMC Cancer Center at UPMC Presbyterian
		Clinical Trial Office - UPMC Cancer Center at UPMC Presbyterian	Ph:  412-647-2811
	UPMC Cancer Center at UPMC St. Margaret
		Susan (Maffey) Rakfal	Ph:  412-781-3744
	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
		Judith Figura, MD	Ph:  412-578-1034
	Seneca
	UPMC Cancer Center at UPMC Northwest
		Susan (Maffey) Rakfal	Ph:  814-676-7900
	State College
	Mount Nittany Medical Center
		Jerome Derdel, MD	Ph:  814-231-7000
	Uniontown
	UPMC Cancer Center - Uniontown
		Susan (Maffey) Rakfal	Ph:  724-439-8950
	Washington
	Washington Hospital Cancer Center
		Susan (Maffey) Rakfal	Ph:  724-223-7100
	York
	York Cancer Center at Apple Hill Medical Center
		Amit Shah	Ph:  717-741-8180
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
Utah
	Murray
	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
		R. Jeffrey Lee, MD	Ph:  801-408-1146
	Saint George
	Dixie Regional Medical Center - East Campus
		Clinical Trials Office - Dixie Regional Medical Center - East Campus	Ph:  435-688-4167
	Salt Lake City
	LDS Hospital
		R. Jeffrey Lee, MD	Ph:  801-408-1146
	Utah Cancer Specialists at UCS Cancer Center
		R. Jeffrey Lee, MD	Ph:  801-408-1146
Washington
	Yakima
	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
		Clinical Trails Office - North Star Lodge Cancer Center	Ph:  509-574-3422
Wisconsin
	Appleton
	Theda Care Cancer Institute
		Clinical Trials Office - Theda Care Cancer Institute	Ph:  920-380-1500
	La Crosse
	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  307-674-6022

Registry Information
Official Title		Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast, and Prostate Cancer
Trial Start Date		2006-07-11
Registered in ClinicalTrials.gov		NCT00365105
Date Submitted to PDQ		2006-06-05
Information Last Verified		2008-10-13
NCI Grant/Contract Number		CA37422