OBJECTIVES:
Primary
- To compare the proportion of patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone who experience ≥ 1 skeletal-related event during 2 years of treatment with zoledronic acid administered every 12 weeks vs every 4 weeks.
Secondary
- To compare pain scores of these patients, as assessed by the Brief Pain Inventory questionnaire.
- To compare the functional status (ECOG performance status) of these patients.
- To compare the incidence of osteonecrosis of the jaw in these patients.
- To compare the incidence of renal dysfunction in these patients.
- To compare the skeletal morbidity rate of these patients, defined as the number of skeletal-related events per year.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (breast cancer vs prostate cancer vs multiple myeloma), baseline serum creatinine (≤ 1.4 mg/dL vs > 1.4 mg/dL), prior skeletal-related events (no vs yes), and prior oral bisphosphate use (no vs yes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive zoledronic acid IV over ≥ 15 minutes. Courses repeat 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 ≥ 15 minutes. Courses repeat every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients complete the Brief Pain Inventory questionnaire at baseline and then every 4 weeks for 2 years.
After completion of study treatment, patients are followed up every 4 weeks for 2 years from registration.
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of one of the following:
- Breast adenocarcinoma
- Prostate adenocarcinoma
- Multiple myeloma
- Has ≥ 1 site of bone metastasis or bone involvement by radiologic imaging, including radiography, computed tomography (CT), PET scan, PET/CT scan, magnetic resonance imaging, bone scan, or skeletal survey
- Indeterminate lesions should be confirmed by a second imaging method
- No known brain metastases
- Patients who develop brain metastases during the study are allowed to continue study treatment as assigned
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Creatinine clearance ≥ 30 mL/min
- Corrected serum calcium ≥ 8.0 mg/dL and < 11.6 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- Prior non-investigational chemotherapy, biologic therapy, and endocrine therapy in the adjuvant or metastatic setting allowed
- No prior treatment with IV bisphosphonates
- Prior oral bisphosphonates allowed
- No concurrent oral bisphosphonates
- No prior treatment with radiopharmaceuticals
- Prior radioactive iodine allowed
- Prior brachytherapy allowed for patients with prostate cancer
- No prior denosumab
- Prior radiotherapy to bone is allowed, provided that at least one site of bone metastasis has not been irradiated and radiation is completed prior to registration
- There should be no plan for radiotherapy to non-irradiated sites of bone metastases
- No concurrent investigational agent(s)
- No concurrent treatment with other agents expected to alter osteoclast activity (e.g., calcitonin, mithramycin, gallium nitrate, or any other bisphosphonate)
- Concurrent non-investigational antineoplastic therapies, including antiandrogens, other hormonal agents, cytotoxic chemotherapy agents, and biologic response modifiers allowed
- No concurrent investigational agents
- Concurrent standard radiotherapy to non-bony sites allowed
Last updated: 04/17/2012
NCT ID: NCT00869206
IRB Number:09-003335
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