Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone
NCT ID: NCT00003884
Last Updated: 2013-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
1998-08-31
2001-01-31
Brief Summary
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PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in treating patients who have solid tumors that have spread to the bone.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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zoledronic acid
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.5 mg/dL for liver metastases Renal: Creatinine no greater than 3.0 mg/dL Calcium at least 8.0 mg/dL but less than 12.0 mg/dL Cardiovascular: No history of severe cardiovascular disease within past 6 months (e.g., congestive heart failure) No hypertension refractory to treatment No symptomatic coronary artery disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of noncompliance to medical regimen
PRIOR CONCURRENT THERAPY: Biologic therapy: Concurrent biologic response modifier therapies allowed Concurrent marketed cytokine or colony stimulating factor therapies allowed Chemotherapy: Concurrent marketed chemotherapy agents allowed (including open label cooperative trials or for supportive care) Endocrine therapy: Concurrent hormonal agents and steroid therapies allowed Concurrent corticosteroid therapy allowed (for chemotherapy induced nausea/vomiting or spinal compression) Radiotherapy: Concurrent radiotherapy to treat extraskeletal and/or skeletal tumor sites allowed Surgery: Prior surgery to treat or prevent pathological fracture or spinal cord compression allowed Other: At least 30 days since other prior investigational drugs No concurrent bisphosphonate agent At least 30 days since prior bisphosphonate agent (single exposure allowed within prior 12 months)
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Knight, MD
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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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 D.C., 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
St 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
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
Albert Einstein Comprehensive Cancer Center
The Bronx, 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
Countries
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Other Identifiers
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NOVARTIS-4244603011
Identifier Type: -
Identifier Source: secondary_id
CDR0000067052
Identifier Type: -
Identifier Source: org_study_id
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