A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer
A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer
This randomized phase III trial studies two different schedules of zoledronic acid to compare how well they work in reducing bone-related complications in patients with breast cancer, prostate cancer, or multiple myeloma that has spread to other places in the body and have bone involvement. Bone-related complications are a major cause of morbidity in patients with metastatic prostate cancer, breast cancer, and multiple myeloma. Zoledronic acid may stop the growth of cancer cells in the bone and may help relieve some of the symptoms caused by bone metastases. It is not yet known whether giving zoledronic acid more or less frequently is more effective in treating patients with metastatic cancer that has spread to the bone.
PRIMARY OBJECTIVES:
I. To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.
SECONDARY OBJECTIVES:
I. To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.
II. To compare the functional status (Eastern Cooperative Oncology Group [ECOG] performance status) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.
III. To compare the incidence of osteonecrosis of the jaw in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.
IV. To compare the incidence of renal dysfunction in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.
V. To compare the skeletal morbidity rate of these patients, defined as the number of skeletal-related events per year, of patients receiving every 12 week dosing to those receiving every 4 week dosing.
VI. To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.
VII. To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for each subgroup of patients with either breast cancer, prostate cancer, or multiple myeloma, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive zoledronic acid intravenously (IV) over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks for 2 years from registration.
Eligibility Criteria:
Fairbanks, Alaska 99701, United States
Northridge, California 91328, United States
Grand Junction, Colorado 81502, United States
Hartford, Connecticut 06105, United States
New Britain, Connecticut 06050, United States
Washington D.C., District of Columbia 20002, United States
Washington D.C., District of Columbia 20007, United States
Fort Lauderdale, Florida 33308, United States
Orlando, Florida 32803-1273, United States
Savannah, Georgia 31403-3089, United States
Savannah, Georgia 31405, United States
Boise, Idaho 83706, United States
Boise, Idaho 83712, United States
Moline, Illinois 61265, United States
Beech Grove, Indiana 46107, United States
La Porte, Indiana 46350, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Wichita, Kansas 67214, United States
Baltimore, Maryland 21237, United States
Largo, Maryland 20774, United States
Springfield, Massachusetts 01199, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Columbia, Missouri 65203, United States
St Louis, Missouri 63110, United States
Billings, Montana 59102, United States
Missoula, Montana 59807, United States
Grand Island, Nebraska 68803, United States
North Platte, Nebraska 69103, United States
Omaha, Nebraska 68198-6805, United States
Concord, New Hampshire 03301, United States
Marlton, New Jersey 08053, United States
Neptune City, New Jersey 07753, United States
Voorhees Township, New Jersey 08043, United States
Voorhees Township, New Jersey 08043, United States
Cooperstown, New York 13326, United States
East Syracuse, New York 13057, United States
Lake Success, New York 11042, United States
Manhasset, New York 11030, United States
Staten Island, New York 10305, United States
White Plains, New York 10601, United States
Pinehurst, North Carolina 28374, United States
Wilmington, North Carolina 28401, United States
Winston-Salem, North Carolina 27103, United States
Winston-Salem, North Carolina 27157-1096, United States
Columbus, Ohio 43210-1240, United States
Wright-Patterson Air Force Base, Ohio 45433-5529, United States
Portland, Oregon 97213-2967, United States
Allentown, Pennsylvania 18105, United States
Drexel Hill, Pennsylvania 19026, United States
East Stroudsburg, Pennsylvania 18301, United States
Scranton, Pennsylvania 18510, United States
Wilkes-Barre, Pennsylvania 18711, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
Fairfax, Virginia 22031, United States
Yakima, Washington 98902, United States
Huntington, West Virginia 25702, United States
Green Bay, Wisconsin 54301-3526, United States
Green Bay, Wisconsin 54311, United States
Manitowoc, Wisconsin 54221-1450, United States
Summit, Wisconsin 53066, United States
Wausau, Wisconsin 54401, United States