Spots Global Cancer Trial Database for Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone
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Trial Identification
Brief Title: Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Zoledronate (4 and 8 mg) Administered Intravenously as an Adjuvant to Anticancer Therapy to Patients With Any Cancer With Bone Metastases Other Than Breast Cancer, Multiple Myeloma or Prostate Cancer
Study ID: NCT00003884
Study Description
Brief Summary: RATIONALE: Zoledronate may help to relieve some of the symptoms caused by bone metastases. It is not yet known if zoledronate is more effective than no further therapy in relieving symptoms of bone metastases or preventing disease progression. PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in treating patients who have solid tumors that have spread to the bone.
Detailed Description: OBJECTIVES: I. Assess the safety and efficacy of zoledronate in patients with any solid tumor cancer with bone metastases other than breast or prostate cancer. II. Assess the efficacy of zoledronate in preventing skeletal-related events including tumor induced hypercalcemia (TIH), time to first occurrence of skeletal-related event or TIH, skeletal morbidity rate, time to progression of bone metastases, overall survival, and time to overall disease progression in these patients. III. Assess the quality of life and pain in these patients on these regimens. OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified into two groups: patients with lung cancer and patients with all other solid tumor cancers. Patients are randomly assigned to receive 1 of the following treatments: Arm I: Patients receive intravenous zoledronate over 5 minutes every 3 weeks for 9 months. Arm II: Patients receive intravenous zoledronate at a higher dose over 5 minutes every 3 weeks for 9 months. Arm III: Patients receive intravenous placebo over 5 minutes every 3 weeks for 9 months. All patients receive oral calcium daily, and an oral multivitamin supplement. Quality of life is assessed prior to therapy, then at months 3, 6, and 9. Patients are followed every 6 months for survival. PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study within 12 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
SORRA Research Center, Birmingham, Alabama, United States
Brookwood ACCC, Birmingham, Alabama, United States
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States
Highlands Oncology Group, Springdale, Arkansas, United States
Columbia South Valley Hospital, Gilroy, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Southwest Cancer Care, Poway, California, United States
Cancer and Blood Institute of the Desert, Rancho Mirage, California, United States
Oncology Clinic, P.C., Colorado Springs, Colorado, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington, District of Columbia, United States
Veterans Affairs Medical Center - Miami, Miami, Florida, United States
Oncology-Hematology Group of South Florida, Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
American Medical Research Institute, Inc., Atlanta, Georgia, United States
Oncology Care Center - Belleville, Belleville, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Louisiana State University Medical Center, Lafayette, Louisiana, United States
Ochsner Clinic, New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States
Maine Center for Cancer Medicine and Blood Disorders, Scarborough, Maine, United States
Greater Baltimore Medical Center and Cancer Center, Baltimore, Maryland, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
New England Hematology/Oncology Associates, P.C., Wellesley, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Spectrum Health and DeVos Children's Hospital, Grand Rapids, Michigan, United States
St. Mary's/Duluth Clinic Health System, Duluth, Minnesota, United States
Hubert H. Humphrey Cancer Center, Robbinsdale, Minnesota, United States
Kansas City Internal Medicine, Kansas City, Missouri, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
Veterans Affairs Medical Center - Reno, Reno, Nevada, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
Brookdale University Hospital and Medical Center, Brooklyn, New York, United States
North Shore University Hospital, Manhasset, New York, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
Raleigh Internal Medicine, Raleigh, North Carolina, United States
Cleveland Clinic Cancer Center, Cleveland, Ohio, United States
Hematology Oncology Consultants Inc, Columbus, Ohio, United States
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States
Regional Cancer Center - Erie, Erie, Pennsylvania, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Palmetto Hematology/Oncology Associates, Spartanburg, South Carolina, United States
Dial Research Associates, Brentwood, Tennessee, United States
Methodist Hospitals of Memphis, Memphis, Tennessee, United States
Cancer Specialist of South Texas. P.A., Corpus Christi, Texas, United States
University of Texas Health Center at Tyler, Tyler, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Danville Hematology and Oncology, Inc., Danville, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Contact Details
Name: Robert Knight, MD
Affiliation: Novartis Pharmaceuticals
Role: STUDY_CHAIR
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