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

Recruiting in Palo Alto (17 mi)

+503 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion 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

Treatment Details

Interventions

• Zoledronic Acid (Bisphosphonate)

Participant Groups

Group I: Arm II (zoledronic acid every 12 weeks) Experimental Treatment 1 Intervention

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 II: Arm I (zoledronic acid every 4 weeks) Experimental Treatment 1 Intervention

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 is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Zometa for:

• Prevention of skeletal events in patients with bone metastases from solid tumors
• Treatment of tumor-induced hypercalcemia

🇺🇸 Approved in United States as Reclast for:

• Treatment and prevention of osteoporosis in postmenopausal women
• Treatment and prevention of glucocorticoid-induced osteoporosis
• Treatment of Paget's disease of bone

🇨🇦 Approved in Canada as Zometa for:

• Prevention of skeletal events in patients with bone metastases from solid tumors
• Treatment of tumor-induced hypercalcemia
• Treatment of osteoporosis in postmenopausal women

🇯🇵 Approved in Japan as Zometa for:

• Treatment of bone metastases from solid tumors
• Treatment of tumor-induced hypercalcemia
• Treatment of osteoporosis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

East Bay Radiation Oncology Center Castro Valley, CA

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, CT

Tunnell Cancer Center at Beebe Medical Center Lewes, DE

CCOP - Christiana Care Health Services Newark, DE

More Trial Locations

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology Lead Sponsor

National Cancer Institute (NCI) Collaborator

References