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

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00869206

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Metastatic Cancer Multiple Myeloma and Plasma Cell Neoplasm Musculoskeletal Complications Pain Prostate Cancer Urinary Complications	Drug: zoledronic acid	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia breast cancer hemophilia

MedlinePlus related topics: Breast Cancer Cancer Multiple Myeloma Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Proportion of patients with ≥ 1 skeletal-related event within 2 years after randomization [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain as assessed by the Brief Pain Inventory questionnaire [ Designated as safety issue: No ]
ECOG performance status [ Designated as safety issue: No ]
Osteonecrosis of the jaw [ Designated as safety issue: No ]
Renal dysfunction [ Designated as safety issue: No ]
Skeletal morbidity rate [ Designated as safety issue: No ]

Estimated Enrollment:	1758
Study Start Date:	March 2009
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Drug: zoledronic acid Given IV every 4 weeks or every 12 weeks
Experimental: 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.	Drug: zoledronic acid Given IV every 4 weeks or every 12 weeks

Detailed Description:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869206

Show 504 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:	Andrew L. Himelstein, MD	Helen F. Graham Cancer Center at Christiana Hospital
Principal Investigator:	Richard L. Schilsky, MD	University of Chicago

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00869206 History of Changes
Other Study ID Numbers:	CDR0000637947, CALGB-70604
Study First Received:	March 24, 2009
Last Updated:	April 17, 2012
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

pain
musculoskeletal complications
urinary complications
adenocarcinoma of the prostate
stage IV breast cancer
recurrent breast cancer
male breast cancer

stage IV prostate cancer
recurrent prostate cancer
stage III multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
refractory multiple myeloma
bone metastases

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasm Metastasis
Neoplasms, Second Primary
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases

Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Diphosphonates

ClinicalTrials.gov processed this record on May 23, 2012