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RATIONALE: Zoledronic acid may stop the growth of cancer cells in bone and may help relieve
some of the symptoms caused by bone metastases. It is not yet known which schedule of
zoledronic acid is more effective in treating patients with metastatic cancer that has
spread to the bone.
PURPOSE: This randomized phase III trial is studying two different schedules of zoledronic
acid to compare how well they work in treating patients with metastatic breast cancer,
metastatic prostate cancer, or multiple myeloma with bone involvement.
Active, not recruiting
Ages:18 and older
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
Sponsor: Cancer and Leukemia Group B
Phase: Phase 3
Trial ID: NCT00869206
Not Accepting Healthy Volunteers