NCT00869206|CompletedPhase 3ResultsDMC

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

A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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4 other identifiers

CALGB-70604CDR0000637947NCI-2009-01102U10CA037447

Study Type

interventional

Target

1,822

Locations

2 countries

Sites

504

Timeline

RegisteredMar 2009

StartedMar 2009

CompletionJan 2017

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,822

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Mar 2009

Longer than P75 for phase_3

Geographic Reach

2 countries

504 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.8 years study duration

Study Start

First participant enrolled

March 1, 2009

Completed

23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed

5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed

2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

November 7, 2018

Completed

Last Updated

November 7, 2018

Status Verified

October 1, 2018

Enrollment Period

5.3 years

First QC Date

March 24, 2009

Results QC Date

February 14, 2017

Last Update Submit

October 8, 2018

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

Keywords

painProstate Adenocarcinomaurinary complicationsstage IV breast cancerRecurrent Breast Carcinomastage IV prostate cancerrecurrent prostate cancerRecurrent Prostate Carcinomastage I multiple myelomastage II multiple myelomaRefractory Plasma Cell Myelomabone metastases

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization
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 of patients who would have experienced at least one skeletal related event within 24 months after randomization.
2 years

Secondary Outcomes (11)

Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire
from baseline up to 2 years
Average ECOG Performance Status
from baseline up to 2 years
Incidence of Osteonecrosis of the Jaw
from baseline up to 2 years
Incidence of Renal Dysfunction
from baseline up to 2 years
Skeletal Morbidity Rate
from baseline up to 2 years
+6 more secondary outcomes

Study Arms (2)

Arm I (zoledronic acid every 4 weeks)

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.

Drug: zoledronic acid

Arm II (zoledronic acid every 12 weeks)

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.

Drug: zoledronic acid

Interventions

zoledronic acidDRUG

Given IV

Arm I (zoledronic acid every 4 weeks)Arm II (zoledronic acid every 12 weeks)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (504)

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

North Bay Cancer Center

Fairfield, California, 94533, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Camino Medical Group - Treatment Center

Mountain View, California, 94040, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Leavey Cancer Center at Northridge Hospital Medical Center

Northridge, California, 91328, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus