Status:
COMPLETED
Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Adenocarcinoma
DS Stage I Plasma Cell Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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,...
Detailed Description
PRIMARY OBJECTIVES: I. To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
1822 Patients enrolled
Trial Details
Trial ID
NCT00869206
Start Date
March 1 2009
End Date
January 1 2017
Last Update
November 7 2018
Active Locations (504)
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1
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
3
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
4
Valley Medical Oncology Consultants - Castro Valley
Castro Valley, California, United States, 94546