Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029224
• Other study ID #: CZOL446EUS16
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2002
• Last updated: January 30, 2012
• Start date: October 2001
• Est. completion date: November 2002

Study information

• Verified date: January 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2002
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• zoledronic acid

Locations

Country	Name	City	State
United States	Hematology-Oncology Associates PC	Albuquerque	New Mexico
United States	New Mexico Oncology Hematology Consultants	Albuquerque	New Mexico
United States	Osceola Cancer Center	Kissimmee	Florida
United States	Nevada Cancer Center	Las Vegas	Nevada
United States	Hematology Oncology Associates, PC	Medforo	Oregon
United States	Virginia Physicians, Inc	Richmond	Virginia
United States	Stockton Hematology Oncology Medical Group	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score assessed by change from baseline			No
Secondary	Quality of life			No
Secondary	Time in infusion chair			No
Secondary	Safety assessed by adverse events (AEs)			Yes