Back to resultsTreatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions
Primary Purpose
Breast Cancer, Multiple Myeloma, Prostate Cancer
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring bone lesions, breast cancer, multiple myeloma, prostate cancer, bone metastases, pain
Eligibility Criteria
Inclusion Criteria Signed informed consent Greater than 18 years of age Proof of breast cancer, multiple myeloma or prostate cancer Diagnosis of at least one cancer-related bone lesion If patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception ECOG performance status of 0,1 or 2 Ability to read, understand and write English or Spanish language Normal renal function Corrected serum calcium equal to or greater than 8mg/dl Exclusion Criteria clinically symptomatic brain metastases hypersensitivity to Zometa or other bisphosphonates pregnant or lactating
Sites / Locations
- Stockton Hematology Oncology Medical Group
- Osceola Cancer Center
- Nevada Cancer Center
- Hematology-Oncology Associates PC
- New Mexico Oncology Hematology Consultants
- Hematology Oncology Associates, PC
- Virginia Physicians, Inc
Outcomes
Primary Outcome Measures
Pain score assessed by change from baseline
Secondary Outcome Measures
Quality of life
Time in infusion chair
Safety assessed by adverse events (AEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00029224
Brief Title
Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions
Official Title
A Prospective, Multicenter, Open-label Clinical Evaluation of the Effect of IV Zoledronic Acid 4mg on PAIN, QUALITY OF LIFE and TIME IN INFUSION CHAIR in Breast Cancer, Multiple Myeloma, and Prostate Cancer Patients With Cancer-related Bone Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
November 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Multiple Myeloma, Prostate Cancer
Keywords
bone lesions, breast cancer, multiple myeloma, prostate cancer, bone metastases, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Primary Outcome Measure Information:
Title
Pain score assessed by change from baseline
Secondary Outcome Measure Information:
Title
Quality of life
Title
Time in infusion chair
Title
Safety assessed by adverse events (AEs)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Signed informed consent
Greater than 18 years of age
Proof of breast cancer, multiple myeloma or prostate cancer
Diagnosis of at least one cancer-related bone lesion
If patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception
ECOG performance status of 0,1 or 2
Ability to read, understand and write English or Spanish language
Normal renal function
Corrected serum calcium equal to or greater than 8mg/dl Exclusion Criteria
clinically symptomatic brain metastases
hypersensitivity to Zometa or other bisphosphonates
pregnant or lactating
Facility Information:
Facility Name
Stockton Hematology Oncology Medical Group
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Osceola Cancer Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Nevada Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Hematology-Oncology Associates PC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New Mexico Oncology Hematology Consultants
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Hematology Oncology Associates, PC
City
Medforo
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Virginia Physicians, Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions
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