Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started

Description

Summary

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.

Official Title

A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer

Details

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

Keywords

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 Prostate Adenocarcinoma stage IV breast cancer Recurrent Breast Carcinoma stage IV prostate cancer recurrent prostate cancer Recurrent Prostate Carcinoma stage I multiple myeloma stage II multiple myeloma Refractory Plasma Cell Myeloma bone metastases Multiple Myeloma Neoplasms, Plasma Cell Adenocarcinoma Neoplasms Neoplasms, Second Primary Bone Neoplasms Bone Marrow Diseases Neoplasm Metastasis Zoledronic acid Diphosphonates

Eligibility

For people ages 18 years and up

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

Locations

  • Rebecca and John Moores UCSD Cancer Center
    La Jolla California 92093-0658 United States
  • Naval Medical Center - San Diego
    San Diego California 92134 United States
  • Veterans Affairs Medical Center - San Diego
    San Diego California 92161 United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT00869206
Phase
Phase 3
Study Type
Interventional
Last Updated
October 2016