Clinical Trials

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

Location:

Trial status:

Inactive

Why is this study being done?

OBJECTIVES:

Primary

- To compare the proportion of patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone who experience ≥ 1 skeletal-related event during 2 years of treatment with zoledronic acid administered every 12 weeks vs every 4 weeks.

Secondary

- To compare pain scores of these patients, as assessed by the Brief Pain Inventory questionnaire.

- To compare the functional status (ECOG performance status) of these patients.

- To compare the incidence of osteonecrosis of the jaw in these patients.

- To compare the incidence of renal dysfunction in these patients.

- To compare the skeletal morbidity rate of these patients, defined as the number of skeletal-related events per year.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (breast cancer vs prostate cancer vs multiple myeloma), baseline serum creatinine (≤ 1.4 mg/dL vs > 1.4 mg/dL), prior skeletal-related events (no vs yes), and prior oral bisphosphate use (no vs yes). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive zoledronic acid IV over ≥ 15 minutes. Courses repeat 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 ≥ 15 minutes. Courses repeat every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Patients complete the Brief Pain Inventory questionnaire at baseline and then every 4 weeks for 2 years.

After completion of study treatment, patients are followed up every 4 weeks for 2 years from registration.

Who is eligible to participate?

DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of one of the following:

- Breast adenocarcinoma

- Prostate adenocarcinoma

- Multiple myeloma

- Has ≥ 1 site of bone metastasis or bone involvement by radiologic imaging, including radiography, computed tomography (CT), PET scan, PET/CT scan, magnetic resonance imaging, bone scan, or skeletal survey

- Indeterminate lesions should be confirmed by a second imaging method

- No known brain metastases

- Patients who develop brain metastases during the study are allowed to continue study treatment as assigned

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Creatinine clearance ≥ 30 mL/min

- Corrected serum calcium ≥ 8.0 mg/dL and < 11.6 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

- Prior non-investigational chemotherapy, biologic therapy, and endocrine therapy in the adjuvant or metastatic setting allowed

- No prior treatment with IV bisphosphonates

- Prior oral bisphosphonates allowed

- No concurrent oral bisphosphonates

- No prior treatment with radiopharmaceuticals

- Prior radioactive iodine allowed

- Prior brachytherapy allowed for patients with prostate cancer

- No prior denosumab

- Prior radiotherapy 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 radiotherapy to non-irradiated sites of bone metastases

- No concurrent investigational agent(s)

- No concurrent treatment with other agents expected to alter osteoclast activity (e.g., calcitonin, mithramycin, gallium nitrate, or any other bisphosphonate)

- Concurrent non-investigational antineoplastic therapies, including antiandrogens, other hormonal agents, cytotoxic chemotherapy agents, and biologic response modifiers allowed

- No concurrent investigational agents

- Concurrent standard radiotherapy to non-bony sites allowed

Last updated: 04/17/2012

NCT ID:

NCT00869206