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
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.
Interventional
Allocation: Randomized, Primary Purpose: Supportive Care
Robert Knight, MD
Study Chair
Novartis Pharmaceuticals
United States: Federal Government
CDR0000067052
NCT00003884
August 1998
January 2001
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington, District of Columbia 20007 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Greater Baltimore Medical Center and Cancer Center | Baltimore, Maryland 21204 |
Swedish Cancer Institute | Seattle, Washington 98104 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - West Los Angeles | Los Angeles, California 90073 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
University of Texas Health Center at Tyler | Tyler, Texas 75708 |
Veterans Affairs Medical Center - Miami | Miami, Florida 33125 |
Ochsner Clinic | New Orleans, Louisiana 70121 |
Spectrum Health and DeVos Children's Hospital | Grand Rapids, Michigan 49503 |
Brookdale University Hospital and Medical Center | Brooklyn, New York 11212 |
Hematology Oncology Consultants Inc | Columbus, Ohio 43235 |
St. Mary's/Duluth Clinic Health System | Duluth, Minnesota 55805 |
Oncology-Hematology Group of South Florida | Miami, Florida 33176 |
Hubert H. Humphrey Cancer Center | Coon Rapids, Minnesota 55433 |
Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne, Indiana 46885-5099 |
Palmetto Hematology/Oncology Associates | Spartanburg, South Carolina 29303 |
Maine Center for Cancer Medicine and Blood Disorders | Scarborough, Maine 04074 |
Kansas City Internal Medicine | Kansas City, Missouri 64132 |
Danville Hematology and Oncology, Inc. | Danville, Virginia 24541 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Cancer and Blood Institute of the Desert | Rancho Mirage, California 92270 |
Pacific Shores Medical Group | Long Beach, California 90813 |
Brookwood ACCC | Birmingham, Alabama 35209 |
SORRA Research Center | Birmingham, Alabama 35203 |
Highlands Oncology Group | Springdale, Arkansas 72764 |
Columbia South Valley Hospital | Gilroy, California 95020 |
Southwest Cancer Care | Poway, California 92064 |
Oncology Clinic, P.C. | Colorado Springs, Colorado 80909 |
American Medical Research Institute, Inc. | Atlanta, Georgia 30338 |
Oncology Care Center - Belleville | Belleville, Illinois 62226 |
Louisiana State University Medical Center | Lafayette, Louisiana 70502-4016 |
New England Hematology/Oncology Associates, P.C. | Wellesley, Massachusetts 02181 |
Veterans Affairs Medical Center - Reno | Reno, Nevada 89520 |
Raleigh Internal Medicine | Raleigh, North Carolina 27609 |
Regional Cancer Center - Erie | Erie, Pennsylvania 16505 |
Dial Research Associates | Brentwood, Tennessee 37027 |
Methodist Hospitals of Memphis | Memphis, Tennessee 38103 |
Cancer Specialist of South Texas. P.A. | Corpus Christi, Texas 78412 |