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Title:
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A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer -IRB# 09-053B
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Treatments:
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Zoledronic Acid
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Disease Site:
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Cancer control
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Disease SubSite:
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Bone Metastases
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Drug Provided:
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-- none --
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Comments:
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Eligibility:
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Histologically confirmed breast adenocarcinoma, prostate adenocarcinoma, or multiple Myeloma. Has >= 1 site of bone metastasis or bone involvement by radiologic imaging (e.g., radiography, computed tomography, magnetic resonance imaging, or bone scan). No known brain metastases. Patients who develop brain metastases during the study are allowed to continue study treatment as assigned.
Prior non-investigational chemotherapy, biologic therapy, and endocrine therapy in the adjuvant or metastatic setting allowed. No prior treatment with IV bisphosphonates. No prior treatment with radiopharmaceuticals. At least 4 weeks since prior radiotherapy. At least 1 site of bone metastasis must not have been irradiated. 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. Concurrent standard radiotherapy to extraskeletal and/or skeletal tumor sites allowed.
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
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