Trial record 1 of 2 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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00869206
First received: March 24, 2009
Last updated: July 1, 2016
Last verified: July 2016

March 24, 2009
July 1, 2016
March 2009
May 2015   (final data collection date for primary outcome measure)
Proportion of patients with at least one skeletal-related event (SRE) within 2 years after randomization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Proportion of patients with ≥ 1 skeletal-related event within 2 years after randomization [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00869206 on ClinicalTrials.gov Archive Site
  • Pain intensity score as assessed by the Brief Pain Inventory (BPI) questionnaire [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • ECOG performance status [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Incidence of osteonecrosis of the jaw [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Incidence of renal dysfunction [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Skeletal morbidity rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Bone turnover assessed by serum N-telopeptide (NTX) levels [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Proportion of patients having at least one SRE within 24 months after randomization for the subgroups of patients with breast cancer, prostate cancer, and multiple myeloma [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ]
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
This randomized phase III trial studies two different schedules of zoledronic acid to compare how well they work in reducing bone-related complications in patients with breast cancer, prostate cancer, or multiple myeloma that has spread to other places in the body and have bone involvement. Bone-related complications are a major cause of morbidity in patients with metastatic prostate cancer, breast cancer, and multiple myeloma. Zoledronic acid may stop the growth of cancer cells in the bone and may help relieve some of the symptoms caused by bone metastases. It is not yet known whether giving zoledronic acid more or less frequently is more effective in treating patients with metastatic cancer that has spread to the bone.

PRIMARY OBJECTIVES:

I. To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.

SECONDARY OBJECTIVES:

I. To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.

II. To compare the functional status (Eastern Cooperative Oncology Group [ECOG] performance status) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.

III. To compare the incidence of osteonecrosis of the jaw in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.

IV. To compare the incidence of renal dysfunction in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.

V. To compare the skeletal morbidity rate of these patients, defined as the number of skeletal-related events per year, of patients receiving every 12 week dosing to those receiving every 4 week dosing.

VI. To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.

VII. To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for each subgroup of patients with either breast cancer, prostate cancer, or multiple myeloma, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive zoledronic acid intravenously (IV) over at least 15 minutes 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 at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Adenocarcinoma
  • DS Stage I Plasma Cell Myeloma
  • DS Stage II Plasma Cell Myeloma
  • Metastatic Malignant Neoplasm to the Bone
  • Pain
  • Musculoskeletal Complication
  • Urinary Complications
Drug: zoledronic acid
Given IV
  • Experimental: Arm I (zoledronic acid every 4 weeks)
    Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
    Intervention: Drug: zoledronic acid
  • Experimental: Arm II (zoledronic acid every 12 weeks)
    Patients receive zoledronic acid IV over at least 15 minutes 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)

Eligibility Criteria:

  • Histologic documentation of one of the following: breast adenocarcinoma, prostate adenocarcinoma or multiple myeloma
  • At least one site of bone metastasis or bone involvement by radiologic imaging including plain radiograph, computed tomography (CT), positron emission tomography (PET) scan, PET/CT scan, magnetic resonance imaging, bone scan, or skeletal survey; indeterminate lesions should be confirmed by a second imaging method
  • No prior treatment with IV bisphosphonates is allowed; prior treatment with oral bisphosphonates is allowed, but they must be discontinued prior to the initiation of protocol therapy
  • No prior treatment with denosumab
  • No prior treatment with radiopharmaceuticals; prior treatment with radioactive iodine is allowed; prostate cancer patients treated with brachytherapy are eligible
  • Prior radiation therapy 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 radiation therapy to non-irradiated sites of bone metastases
  • Prior adjuvant and metastatic chemotherapy, biologic therapy, and endocrine therapy is allowed
  • No current treatment with investigational agent(s)
  • Patients with known brain metastases are not eligible; patients who develop brain metastases during the study will be allowed to continue treatment as assigned
  • Not pregnant and not nursing
  • ECOG performance status 0-2
  • Calculated creatinine clearance >= 30 mL/min
  • Corrected serum calcium >= 8.0 mg/dL (2.00 mmol/L) and < 11.6 mg/dL (2.90 mmol/L) * Corrected serum calcium should be calculated using standard institutional practices
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00869206
CALGB-70604, CDR0000637947, NCI-2009-01102, U10CA037447
Yes
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Andrew L. Himelstein, MD Helen F. Graham Cancer Center at Christiana Hospital
Alliance for Clinical Trials in Oncology
July 2016

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