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Trial record 1 of 1 for:    70604
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Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00869206
First received: March 24, 2009
Last updated: April 17, 2012
Last verified: April 2012

March 24, 2009
April 17, 2012
March 2009
May 2015   (final data collection date for primary outcome measure)
Proportion of patients with ≥ 1 skeletal-related event within 2 years after randomization [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00869206 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Metastatic Cancer
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Musculoskeletal Complications
  • Pain
  • Prostate Cancer
  • Urinary Complications
Drug: zoledronic acid
Given IV every 4 weeks or every 12 weeks
  • 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.
    Intervention: Drug: zoledronic acid
  • 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.
    Intervention: Drug: zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1758
Not Provided
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00869206
CDR0000637947, CALGB-70604
Not Provided
Monica M. Bertagnolli, Cancer and Leukemia Group B
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Andrew L. Himelstein, MD Helen F. Graham Cancer Center at Christiana Hospital
Principal Investigator: Richard L. Schilsky, MD University of Chicago
National Cancer Institute (NCI)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP