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
Breast Cancer, Lung Cancer, Metastatic Cancer
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring 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
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically proven diagnosis of solid tumor malignancy of lung, breast, or prostate prior to registration; Appropriate diagnosis for protocol entry, based upon the following minimum diagnostic workup: 2.1 History/physical examination within 8 weeks prior to registration; 2.2 Bone scan within 4 weeks prior to registration; bone metastases must be visible on the scan. Other scanning modalities, such as magnetic resonance imaging (MRI), positron emission tomography (PET) 2.3 Dental evaluation according to the dental exam checklist (carried out by the investigator, the investigator's designee, or by a qualified dental professional [dental hygienist or dentist]), including history of dental surgery (e.g., extraction or implant) within 8 weeks prior to registration and recorded on the dental exam checklist; Note: If the patient has received prior oral bisphosphonate therapy and has had a prior dental evaluation within 8 weeks of registration, the evaluation should not be repeated. 2.4 Complete blood count (CBC)/differential within 2 weeks prior to registration, with adequate bone marrow function defined as follows: White blood cell count (WBC) ≥ 2400 cells/mm^3; Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3; Platelets ≥ 60,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve the required hemoglobin is permitted). 2.5 Serum creatinine < 3 mg/dL (265 μmol/L) within 2 weeks prior to registration; 2.6 Total bilirubin < 2.5 mg/dL (43 μmol/L) within 2 weeks prior to registration; 2.7 Pregnancy test (urine dipstick or serum) for women of childbearing potential within 2 weeks prior to registration; ≥ 18 years of age; Zubrod performance status 0-2 for patients with breast or prostate primaries; Zubrod performance status 0-1 for patients with lung primaries; Patients receiving systemic chemotherapy or hormonal therapy are eligible for this study. See Sections 6.0 and 7.0 for further details. Note: All patients must complete external beam radiation therapy ≥ 14 days prior to registration. If patients have undergone CyberKnife treatment, treatment must be completed ≥ 14 days prior to registration. Patients may have received prior oral bisphosphonate therapy, such as Fosamax® or similar medications. Duration of bisphosphonate treatment prior to study entry must be documented, and all bisphosphonates other than the study drug must be discontinued prior to registration. Women of childbearing potential and male participants must agree to practice an adequate means of birth control throughout their participation in the study. Patient must sign study specific informed consent prior to study entry. Exclusion Criteria Patients with brain metastases and/or spinal cord compression are excluded. Note: Patients with no evidence of disease in the brain after treatment for brain metastases are eligible. Patients with painful bone metastases are not permitted until these bone metastases are successfully treated (for example by external beam irradiation) prior to registration, and the patient has stable pain for at least 2 weeks after that treatment (Stable pain is defined for this study as a patient response of 1, 2, or 3 on Questions 4 and 5 of The Brief Pain Inventory (BPI). Prior treatment with Strontium-89 or Samarium-153 for bone metastases. Treatment for more than 6 months with IV bisphosphonates prior to study entry; Treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to registration Severe, active co-morbidity, defined as follows: 6.1 Evidence in the six months prior to study entry of uncontrolled congestive heart failure, hypertension refractory to treatment, or symptomatic coronary artery disease; 6.2 Current, active dental problems within 4 weeks of registration, including infection of the teeth or jawbone (maxilla or mandible); dental or fixture trauma; current or prior diagnosis of osteonecrosis of the jaw (ONJ); exposed bone in the mouth; or slow healing after dental procedures; 6.3 Dental surgery (e.g., extractions, implants) within 6 weeks of study entry and while receiving study treatment; for patients who require dental surgery, there are no data to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw (ONJ) [see Section 7.2.4]. 6.4 Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients. Pregnant or lactating patients are excluded, as treatment may be harmful to embryos and/or nursing infants.
Sites / Locations
- Providence Cancer Center at Providence Hospital
- Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
- Mercy Cancer Center at Mercy San Juan Medical Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
- Radiation Oncology Center - Roseville
- Radiological Associates of Sacramento Medical Group, Incorporated
- General Robert Huyser Cancer Center at David Grant Medical Center
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- Integrated Community Oncology Network
- Baptist Cancer Institute - Jacksonville
- Integrated Community Oncology Network at Southside Cancer Center
- Baptist Medical Center South
- CCOP - Mount Sinai Medical Center
- Miami Cancer Center at Mercy Hospital
- Integrated Community Oncology Network - Orange Park
- Florida Cancer Center - Palatka
- Bay Medical
- Flagler Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- John B. Amos Cancer Center
- Northeast Georgia Medical Center
- Northwest Community Hospital
- Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
- Veterans Affairs Medical Center - Hines
- Advocate Christ Medical Center
- Advocate Lutheran General Cancer Care Center
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Cancer Institute at St. John's Hospital
- CCOP - Carle Cancer Center
- Center for Cancer Care at Goshen General Hospital
- Cancer Center at Ball Memorial Hospital
- CCOP - Northern Indiana CR Consortium
- McFarland Clinic, PC
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- Siouxland Hematology-Oncology Associates, LLP
- Lawrence Memorial Hospital
- CCOP - Wichita
- Central Baptist Hospital
- Tulane Cancer Center Office of Clinical Research
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
- St. Agnes Hospital Cancer Center
- Hudner Oncology Center at Saint Anne's Hospital - Fall River
- Cape Cod Hospital
- Saint Joseph Mercy Cancer Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- St. John Macomb Hospital
- CentraCare Clinic - River Campus
- Regional Cancer Center at Singing River Hospital
- Truman Medical Center - Hospital Hill
- CCOP - Kansas City
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Northern Rockies Radiation Oncology Center
- Billings Clinic - Downtown
- Great Falls Clinic - Main Facility
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Princeton Radiation Oncology Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- University Medical Center at Princeton
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
- Cancer Institute of New Jersey at Cooper - Voorhees
- New Mexico Cancer Center
- New York Methodist Hospital
- Sands Cancer Center
- Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
- Highland Hospital of Rochester
- Lipson Cancer and Blood Center at Rochester General Hospital
- University Radiation Oncology at Parkridge Hospital
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Mission Hospitals - Memorial Campus
- Presbyterian Cancer Center at Presbyterian Hospital
- Wayne Radiation Oncology
- Trinity CancerCare Center
- McDowell Cancer Center at Akron General Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- Radiation Oncology Center
- Barberton Citizens Hospital
- Mercy Cancer Center at Mercy Medical Center
- Adena Regional Medical Center
- CCOP - Columbus
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Middletown Regional Hospital
- Charles F. Kettering Memorial Hospital
- MedCentral - Mansfield Hospital
- Cancer Care Center, Incorporated
- UVMC Cancer Care Center at Upper Valley Medical Center
- Cancer Treatment Center
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Rosenfeld Cancer Center at Abington Memorial Hospital
- UPMC Cancer Center at Beaver Medical Center
- UPMC Cancer Center at Jefferson Regional Medical Center
- Northeast Radiation Oncology Center
- UPMC Cancer Center - Arnold Palmer Pavilion
- UPMC Cancer Center at the John P. Murtha Pavilion
- UPMC Cancer Center at UPMC McKeesport
- UPMC - Moon
- UPMC Cancer Center - Natrona Heights
- Jameson Memorial Hospital - North Campus
- UPMC - Shadyside
- UPMC Cancer Center at Magee-Womens Hospital
- UPMC Cancer Center at UPMC Presbyterian
- UPMC Cancer Center at UPMC St. Margaret
- UPMC Cancer Center at UPMC Passavant
- UPMC Cancer Center - Upper St. Clair
- UPMC Cancer Center at UPMC Northwest
- Mount Nittany Medical Center
- UPMC Cancer Center - Uniontown
- Washington Hospital Cancer Center
- York Cancer Center at Apple Hill Medical Center
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Greenville
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- LDS Hospital
- St. Francis Hospital
- Good Samaritan Cancer Center
- CCOP - Virginia Mason Research Center
- Franciscan Cancer Center at St. Joseph Medical Center
- CCOP - Northwest
- MultiCare Regional Cancer Center at Tacoma General Hospital
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Theda Care Cancer Institute
- Bellin Memorial Hospital
- Riverview UW Cancer Center at Riverview Hospital
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Zoledronic acid
Zoledronic acid + Radiopharmaceuticals
Zoledronic acid, vitamin D and calcium supplements.
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.