Home
Clinical Trials
Zoledronic Acid in Treating P...

Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement

Last Updated: 2018-11-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1822 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions

NCT00029224

Breast Cancer Multiple Myeloma Prostate Cancer

COMPLETED PHASE4

Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone

NCT00003884

Hypercalcemia of Malignancy Lung Cancer Metastatic Cancer +2 more

COMPLETED PHASE3

Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer

NCT00022087

Breast Cancer Osteoporosis

COMPLETED PHASE3

Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions

NCT00375427

Breast Cancer With Bone Metastasis

COMPLETED PHASE3

Safety and Efficacy Study of Concomitant Radiotherapy and Zoledronic Acid for Bone Metastases Palliation

NCT00264420

Bone Metastases Breast Cancer Lung Cancer +1 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

zoledronic acid

Intervention Type DRUG

Given IV

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.

Group Type EXPERIMENTAL

zoledronic acid

Intervention Type DRUG

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

zoledronic acid

Given IV

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew L. Himelstein, MD

Role: STUDY_CHAIR

Helen F. Graham Cancer Center at Christiana Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, United States

Site Status

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, United States

Site Status

North Bay Cancer Center

Fairfield, California, United States

Site Status

Valley Medical Oncology

Fremont, California, United States

Site Status

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

Memorial Medical Center

Modesto, California, United States

Site Status

Camino Medical Group - Treatment Center

Mountain View, California, United States

Site Status

El Camino Hospital Cancer Center

Mountain View, California, United States

Site Status