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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
  • Breast Adenocarcinoma
  • DS Stage I Plasma Cell Myeloma
  • Metastatic Cancer
  • DS Stage II Plasma Cell Myeloma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Musculoskeletal Complications
  • Metastatic Malignant Neoplasm to the Bone
  • Pain
  • Prostate Cancer
  • Musculoskeletal Complication
  • Urinary Complications
What is the purpose of this trial?

This randomized phase III trial studies two different schedules of zoledronic acid to compare how well they work in reducing bone-related complications in patients with breast cancer, prostate cancer, or multiple myeloma that has spread to other places in the body and have bone involvement. Bone-related complications are a major cause of morbidity in patients with metastatic prostate cancer, breast cancer, and multiple myeloma. Zoledronic acid may stop the growth of cancer cells in the bone and may help relieve some of the symptoms caused by bone metastases. It is not yet known whether giving zoledronic acid more or less frequently is more effective in treating patients with metastatic cancer that has spread to the bone.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Eligibility Criteria:

- Histologic documentation of one of the following: breast adenocarcinoma, prostate
adenocarcinoma or multiple myeloma

- At least one site of bone metastasis or bone involvement by radiologic imaging
including plain radiograph, computed tomography (CT), positron emission tomography
(PET) scan, PET/CT scan, magnetic resonance imaging, bone scan, or skeletal survey;
indeterminate lesions should be confirmed by a second imaging method

- No prior treatment with IV bisphosphonates is allowed; prior treatment with oral
bisphosphonates is allowed, but they must be discontinued prior to the initiation of
protocol therapy

- No prior treatment with denosumab

- No prior treatment with radiopharmaceuticals; prior treatment with radioactive iodine
is allowed; prostate cancer patients treated with brachytherapy are eligible

- Prior radiation therapy 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 radiation therapy to non-irradiated sites of bone
metastases

- Prior adjuvant and metastatic chemotherapy, biologic therapy, and endocrine therapy
is allowed

- No current treatment with investigational agent(s)

- Patients with known brain metastases are not eligible; patients who develop brain
metastases during the study will be allowed to continue treatment as assigned

- Not pregnant and not nursing

- ECOG performance status 0-2

- Calculated creatinine clearance >= 30 mL/min

- Corrected serum calcium >= 8.0 mg/dL (2.00 mmol/L) and < 11.6 mg/dL (2.90 mmol/L) *
Corrected serum calcium should be calculated using standard institutional practices

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

Investigator Name:

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

Other Information

Sponsor: Alliance for Clinical Trials in Oncology
Phase: Phase 3
Trial ID: NCT00869206
Volunteers:  Not Accepting Healthy Volunteers

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