A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,822
- 试验地点
- 500
- 主要终点
- Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I (zoledronic acid every 4 weeks)
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: zoledronic acid (Drug)
Arm II (zoledronic acid every 12 weeks)
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.
干预措施: zoledronic acid (Drug)
结局指标
主要结局
Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization
时间窗: 2 years
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 of patients who would have experienced at least one skeletal related event within 24 months after randomization.
次要结局
- Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire(from baseline up to 2 years)
- Average ECOG Performance Status(from baseline up to 2 years)
- Incidence of Osteonecrosis of the Jaw(from baseline up to 2 years)
- Incidence of Renal Dysfunction(from baseline up to 2 years)
- Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Multiple Myeloma(from baseline up to 24 months)
- Skeletal Morbidity Rate(from baseline up to 2 years)
- Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Breast Cancer)(from baseline up to 2 years)
- Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Breast Cancer(from baseline up to 24 months)
- Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Prostate Cancer(from baseline up to 24 months)
- Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Prostate Cancer)(from baseline up to 24 months)
- Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Multiple Myeloma)(from baseline up to 24 months)