Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Breast Adenocarcinoma DS Stage I Plasma Cell Myeloma DS Stage II Plasma Cell Myeloma Metastatic Malignant Neoplasm to the Bone Pain Musculoskeletal Complication Urinary Complications | Drug: zoledronic acid | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
| Official Title: | A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer |
- Proportion of patients with at least one skeletal-related event (SRE) within 2 years after randomization [ Time Frame: 2 years ]
- Pain intensity score as assessed by the Brief Pain Inventory (BPI) questionnaire [ Time Frame: Up to 2 years ]
- ECOG performance status [ Time Frame: Up to 2 years ]
- Incidence of osteonecrosis of the jaw [ Time Frame: Up to 2 years ]
- Incidence of renal dysfunction [ Time Frame: Up to 2 years ]
- Skeletal morbidity rate [ Time Frame: 2 years ]
- Bone turnover assessed by serum N-telopeptide (NTX) levels [ Time Frame: Up to 2 years ]
- Proportion of patients having at least one SRE within 24 months after randomization for the subgroups of patients with breast cancer, prostate cancer, and multiple myeloma [ Time Frame: 24 months ]
| Estimated Enrollment: | 1758 |
| Study Start Date: | March 2009 |
| Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (zoledronic acid every 4 weeks)
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Drug: zoledronic acid
Given IV
|
|
Experimental: Arm II (zoledronic acid every 12 weeks)
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Drug: zoledronic acid
Given IV
|
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, or multiple myeloma involving bone, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.
SECONDARY OBJECTIVES:
I. To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.
II. To compare the functional status (Eastern Cooperative Oncology Group [ECOG] performance status) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.
III. To compare the incidence of osteonecrosis of the jaw in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.
IV. To compare the incidence of renal dysfunction in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.
V. To compare the skeletal morbidity rate of these patients, defined as the number of skeletal-related events per year, of patients receiving every 12 week dosing to those receiving every 4 week dosing.
VI. To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.
VII. To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for each subgroup of patients with either breast cancer, prostate cancer, or multiple myeloma, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive zoledronic acid intravenously (IV) over at least 15 minutes 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 at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks for 2 years from registration.
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869206
Show 504 Study Locations
| Study Chair: | Andrew L. Himelstein, MD | Helen F. Graham Cancer Center at Christiana Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00869206 History of Changes |
| Other Study ID Numbers: |
CALGB-70604 CDR0000637947 ( Registry Identifier: NCI Physician Data Query ) NCI-2009-01102 ( Registry Identifier: NCI Clinical Trial Reporting Program ) U10CA037447 ( U.S. NIH Grant/Contract ) |
| First Submitted: | March 24, 2009 |
| First Posted: | March 25, 2009 |
| Last Update Posted: | October 12, 2017 |
| Last Verified: | October 2016 |
Keywords provided by Alliance for Clinical Trials in Oncology:
|
pain Prostate Adenocarcinoma urinary complications stage IV breast cancer Recurrent Breast Carcinoma stage IV prostate cancer |
recurrent prostate cancer Recurrent Prostate Carcinoma stage I multiple myeloma stage II multiple myeloma Refractory Plasma Cell Myeloma bone metastases |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Adenocarcinoma Neoplasms Neoplasms, Second Primary Bone Neoplasms Bone Marrow Diseases Neoplasm Metastasis 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 Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Site Bone Diseases Musculoskeletal Diseases Neoplastic Processes Pathologic Processes Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs |