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

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Trial Conditions
  • Breast Cancer
  • Metastatic Cancer
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Musculoskeletal Complications
  • Pain
  • Prostate Cancer
  • Urinary Complications
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?


18 and older




- 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


- 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 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

- 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

- No concurrent investigational agents

- Concurrent standard radiotherapy to non-bony sites allowed

Gender: Both
Steward Physician(s)
  • Andrew L. Himelstein, MD
  • Richard L. Schilsky, MD
  • St. Elizabeth's Medical Center - Active, not recruiting
  • Holy Family Hospital - Active, not recruiting
Trial Interventions
  • zoledronic acid
Physician Researcher

Investigator Name:

  • Andrew L. Himelstein, MD
  • Richard L. Schilsky, MD

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 3
Trial ID: NCT00869206
Volunteers:  Not Accepting Healthy Volunteers

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