Pain Clinical Trial
Official title:
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.
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