Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Zoledronic acid may stop the growth of cancer cells in bone and may help relieve some of the symptoms caused by bone metastases. It is not yet known which schedule of zoledronic acid is more effective in treating patients with metastatic cancer that has spread to the bone.

PURPOSE: This randomized phase III trial is studying two different schedules of zoledronic acid to compare how well they work in treating patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma with bone involvement.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Andrew Louis Himelstein

Study Chair

Richard L. Schilsky

Principal Investigator

U.S.A.
California
	Pomona
	Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
		Yallapragada S. Rao	Ph: 909-865-9555
Illinois
	Chicago
	Cancer and Leukemia Group B
		James L Khatcheressian	Ph: 804-287-3000
			Email: jkhatch@vacancer.com
Indiana
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Rao Nattam	Ph: 260-484-8830
			Email: ledgar@fwmoh.com
Iowa
	Dubuque
	Wendt Regional Cancer Center at Finley Hospital
		James R. Baer	Ph: 641-422-6304
Minnesota
	Fergus Falls
	Lake Region Healthcare Corporation-Cancer Care
		Preston D. Steen	Ph: 701-234-6161

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00869206
Information obtained from ClinicalTrials.gov on February 14, 2013

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