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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 (NCT00003884)

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.
  • Drug: zoledronic acid
    • Procedure: quality-of-life assessment
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      Accepts Healthy Volunteers
      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.

      55 locations

      United States (55)
      • SORRA Research Center
        Birmingham, Alabama, United States, 35203
      • Brookwood ACCC
        Birmingham, Alabama, United States, 35209
      • University of Alabama Comprehensive Cancer Center
        Birmingham, Alabama, United States, 35294
      • Highlands Oncology Group
        Springdale, Arkansas, United States, 72764
      • Columbia South Valley Hospital
        Gilroy, California, United States, 95020
      • Pacific Shores Medical Group
        Long Beach, California, United States, 90813
      • Veterans Affairs Medical Center - West Los Angeles
        Los Angeles, California, United States, 90073
      • Jonsson Comprehensive Cancer Center, UCLA
        Los Angeles, California, United States, 90095-1781
      • Southwest Cancer Care
        Poway, California, United States, 92064
      • Cancer and Blood Institute of the Desert
        Rancho Mirage, California, United States, 92270
      • Oncology Clinic, P.C.
        Colorado Springs, Colorado, United States, 80909
      • Veterans Affairs Medical Center - Denver
        Denver, Colorado, United States, 80220
      • Vincent T. Lombardi Cancer Research Center, Georgetown University
        Washington, District of Columbia, United States, 20007
      • Veterans Affairs Medical Center - Miami
        Miami, Florida, United States, 33125
      • Oncology-Hematology Group of South Florida
        Miami, Florida, United States, 33176
      • H. Lee Moffitt Cancer Center and Research Institute
        Tampa, Florida, United States, 33612
      • American Medical Research Institute, Inc.
        Atlanta, Georgia, United States, 30338
      • Oncology Care Center - Belleville
        Belleville, Illinois, United States, 62226
      • Fort Wayne Medical Oncology and Hematology, Inc.
        Fort Wayne, Indiana, United States, 46885-5099
      • University of Iowa Hospitals and Clinics
        Iowa City, Iowa, United States, 52242
      • Louisiana State University Medical Center
        Lafayette, Louisiana, United States, 70502-4016
      • Ochsner Clinic
        New Orleans, Louisiana, United States, 70121
      • Louisiana State University Health Sciences Center - Shreveport
        Shreveport, Louisiana, United States, 71130-3932
      • Maine Center for Cancer Medicine and Blood Disorders
        Scarborough, Maine, United States, 04074
      • Greater Baltimore Medical Center and Cancer Center
        Baltimore, Maryland, United States, 21204
      • New England Medical Center Hospital
        Boston, Massachusetts, United States, 02111
      • New England Hematology/Oncology Associates, P.C.
        Wellesley, Massachusetts, United States, 02181
      • Henry Ford Hospital
        Detroit, Michigan, United States, 48202
      • Spectrum Health and DeVos Children's Hospital
        Grand Rapids, Michigan, United States, 49503
      • St. Mary's/Duluth Clinic Health System
        Duluth, Minnesota, United States, 55805
      • Hubert H. Humphrey Cancer Center
        Robbinsdale, Minnesota, United States, 55422
      • Kansas City Internal Medicine
        Kansas City, Missouri, United States, 64132
      • Missouri Baptist Cancer Center
        Saint Louis, Missouri, United States, 63131
      • Veterans Affairs Medical Center - Reno
        Reno, Nevada, United States, 89520
      • Veterans Affairs Medical Center - East Orange
        East Orange, New Jersey, United States, 07018-1095
      • Albert Einstein Comprehensive Cancer Center
        Bronx, New York, United States, 10461
      • Brookdale University Hospital and Medical Center
        Brooklyn, New York, United States, 11212
      • North Shore University Hospital
        Manhasset, New York, United States, 11030
      • New York Presbyterian Hospital - Cornell Campus
        New York, New York, United States, 10021
      • University of Rochester Cancer Center
        Rochester, New York, United States, 14642
      • Raleigh Internal Medicine
        Raleigh, North Carolina, United States, 27609
      • Cleveland Clinic Cancer Center
        Cleveland, Ohio, United States, 44195
      • Hematology Oncology Consultants Inc
        Columbus, Ohio, United States, 43235
      • University of Oklahoma College of Medicine
        Oklahoma City, Oklahoma, United States, 73190
      • Regional Cancer Center - Erie
        Erie, Pennsylvania, United States, 16505
      • Milton S. Hershey Medical Center
        Hershey, Pennsylvania, United States, 17033
      • University of Pittsburgh Cancer Institute
        Pittsburgh, Pennsylvania, United States, 15213
      • Palmetto Hematology/Oncology Associates
        Spartanburg, South Carolina, United States, 29303
      • Dial Research Associates
        Brentwood, Tennessee, United States, 37027
      • Methodist Hospitals of Memphis
        Memphis, Tennessee, United States, 38103
      • Cancer Specialist of South Texas. P.A.
        Corpus Christi, Texas, United States, 78412
      • University of Texas Health Center at Tyler
        Tyler, Texas, United States, 75710
      • Huntsman Cancer Institute
        Salt Lake City, Utah, United States, 84132
      • Danville Hematology and Oncology, Inc.
        Danville, Virginia, United States, 24541
      • Swedish Cancer Institute
        Seattle, Washington, United States, 98104
      31 July, 1998
      19 February, 2013
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