Trial record 1 of 1 for:    70604
Previous Study | Return to List | Next Study

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 504 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
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:
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
Multiple Myeloma
Neoplasm Metastasis
Neoplasms
Neoplasms, Plasma Cell
Neoplasms, Second Primary
Plasmacytoma
Prostatic Neoplasms
Blood Protein Disorders
Breast Diseases
Cardiovascular Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms by Site
Neoplastic Processes
Paraproteinemias
Pathologic Processes
Prostatic Diseases
Skin Diseases
Urogenital Neoplasms
Vascular Diseases
Diphosphonates
Zoledronic acid

ClinicalTrials.gov processed this record on October 22, 2014