|Phase III||Treatment||Closed||18 and over||NCI, Other||CDR0000637947|
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.
Further Study Information
- To compare the proportion of patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone who experience ≥ 1 skeletal-related event during 2 years of treatment with zoledronic acid administered every 12 weeks vs every 4 weeks.
- To compare pain scores of these patients, as assessed by the Brief Pain Inventory questionnaire.
- To compare the functional status (ECOG performance status) of these patients.
- To compare the incidence of osteonecrosis of the jaw in these patients.
- To compare the incidence of renal dysfunction in these patients.
- To compare the skeletal morbidity rate of these patients, defined as the number of skeletal-related events per year.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (breast cancer vs prostate cancer vs multiple myeloma), baseline serum creatinine (≤ 1.4 mg/dL vs > 1.4 mg/dL), prior skeletal-related events (no vs yes), and prior oral bisphosphate use (no vs yes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive zoledronic acid IV over ≥ 15 minutes. Courses repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive zoledronic acid IV over ≥ 15 minutes. Courses repeat every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients complete the Brief Pain Inventory questionnaire at baseline and then every 4 weeks for 2 years.
After completion of study treatment, patients are followed up every 4 weeks for 2 years from registration.
- 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 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
Trial Lead Organizations/Sponsors
Cancer and Leukemia Group BNational Cancer Institute
|Andrew Louis Himelstein||Study Chair|
|Richard L. Schilsky||Principal Investigator|
|Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center|
|Yallapragada S. Rao||Ph: 909-865-9555|
|Cancer and Leukemia Group B|
|James L Khatcheressian||Ph: 804-287-3000|
|Fort Wayne Medical Oncology and Hematology|
|Sreenivasa Rao Nattam||Ph: 260-484-8830|
|Wendt Regional Cancer Center at Finley Hospital|
|James R. Baer||Ph: 641-422-6304|
|Lake Region Healthcare Corporation-Cancer Care|
|Preston D. Steen||Ph: 701-234-6161|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00869206
Information obtained from ClinicalTrials.gov on February 14, 2013
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