Overview

This trial is active, not recruiting.

Conditions 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
Treatment zoledronic acid
Phase phase 3
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date March 2009
End date May 2015
Trial size 1758 participants
Trial identifier NCT00869206, CALGB-70604, CDR0000637947, NCI-2009-01102, U10CA037447

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, 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
zoledronic acid
Given IV
(Experimental)
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.
zoledronic acid
Given IV

Primary Outcomes

Measure
Proportion of patients with at least one skeletal-related event (SRE) within 2 years after randomization
time frame: 2 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.