Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Metastatic Cancer Multiple Myeloma and Plasma Cell Neoplasm Musculoskeletal Complications Pain Prostate Cancer Urinary Complications |
Drug: zoledronic acid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer |
- Proportion of patients with ≥ 1 skeletal-related event within 2 years after randomization [ Designated as safety issue: No ]
- Pain as assessed by the Brief Pain Inventory questionnaire [ Designated as safety issue: No ]
- ECOG performance status [ Designated as safety issue: No ]
- Osteonecrosis of the jaw [ Designated as safety issue: No ]
- Renal dysfunction [ Designated as safety issue: No ]
- Skeletal morbidity rate [ Designated as safety issue: No ]
| Estimated Enrollment: | 1758 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
Drug: zoledronic acid
Given IV every 4 weeks or every 12 weeks
|
|
Experimental: 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.
|
Drug: zoledronic acid
Given IV every 4 weeks or every 12 weeks
|
Detailed Description:
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
- 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
Contacts and Locations
Show 504 Study Locations| Study Chair: | Andrew L. Himelstein, MD | Helen F. Graham Cancer Center at Christiana Hospital |
| Principal Investigator: | Richard L. Schilsky, MD | University of Chicago |
More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00869206 History of Changes |
| Other Study ID Numbers: | CDR0000637947, CALGB-70604 |
| Study First Received: | March 24, 2009 |
| Last Updated: | April 17, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
pain musculoskeletal complications urinary complications adenocarcinoma of the prostate stage IV breast cancer recurrent breast cancer male breast cancer |
stage IV prostate cancer recurrent prostate cancer stage III multiple myeloma stage I multiple myeloma stage II multiple myeloma refractory multiple myeloma bone metastases |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasm Metastasis Neoplasms, Second Primary Prostatic Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Zoledronic acid Diphosphonates |
ClinicalTrials.gov processed this record on May 19, 2013