A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer

Inclusion Criteria

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