An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

A 24-Week Blinded Study Conducted at Multiple Centers, Evaluating the Safety and Effectiveness of Various Doses of the Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) When Randomly Assigned to Patients With Breast Cancer That Has Metastasized to Bone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051779
• Other study ID #: CAL-03
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2003
• Last updated: June 23, 2005

Study information

• Verified date: February 2004
• Source: Chugai Pharma USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is intended to evaluate the safety, tolerability, and possible effectiveness of an investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related protein (PTHrP) when compared to zoledronic acid in patients with breast cancer metastatic to bone.

The study will also evaluate the possible effects of both study drugs on performance status, markers of bone metabolism, and skeletal events related to bone metastasis including elevated blood calcium levels, bone pain, metastatic lesions, complications and interventions. The levels of CAL in the blood will also be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Major Inclusion Criteria – Others Stipulated within the Protocol

The study physician must assure you have/are:

• Must be a female at least 18 years of age and be using an effective form of birth control.

• A documented history of breast cancer and at least one bone metastasis that has not been previously treated by radiation or surgery, and is not anticipated to be treated within the next 24 weeks.

• A total body bone scan and other radiographic scan(s) performed on you within 4 weeks prior to or during the screening period sufficient to image all sites of bone metastases.

• You must be willing to perform a daily telephone diary and be willing to keep a paper diary and provide voluntary consent to participate in this study.

Major Exclusion Criteria – Others Stipulated within the Protocol

The study physician must assure you do not have/are not:

• A change in analgesic (pain relief) type medication during the screening period (example, non-narcotic to narcotic).

• Received radiation therapy to any bone metastasis or started a new course of chemotherapy within 3 weeks prior to the screening visit or during the screening period.

• Used any bisphosphonate type drug during the 30 days prior to the anticipated first dose of study drug

• Vertebral spine or weight-bearing bone metastasis that would place you at imminent risk for fracture or surgical intervention.

• Evidence of active infection or immune deficiency, renal failure, abnormal liver function, or a serum calcium level > 10.1 mg/dL.

• Use of any investigational drug within 30 days prior to screening.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastasis

Intervention

Drug:
• CAL

Locations

Country	Name	City	State
United States	Anschutz Cancer Pavilion at the University of Colorado Cancer Center	Aurora	Colorado
United States	Dana-Farber/Harvard Cancer Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	HemOnCare, P.C.	Brooklyn	New York
United States	Rush Cancer Institute	Chicago	Illinois
United States	Ireland Cancer Center	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Palmetto Health	Columbia	South Carolina
United States	Hematology Oncology Consultants, Inc.	Columbus	Ohio
United States	Bay Area Cancer Research Group	Concord	California
United States	Cancer Specialists of South Texas, PA	Corpus Christi	Texas
United States	Center for Oncology Research & Treatment	Dallas	Texas
United States	Josephine Ford Cancer Center	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Frederick Memorial Hospital	Frederick	Maryland
United States	Holy Cross Hospital	Ft. Lauderdale	Florida
United States	Spectrum Health	Grand Rapids	Michigan
United States	California Cancer Care, Inc.	Greenbrae	California
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	Nevada Cancer Center	Las Vegas	Nevada
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Institute of Cancer Therapies	Los Angeles	California
United States	Boston Baskin Cancer Group	Memphis	Tennessee
United States	The Boston Baskin Cancer Group	Memphis	Tennessee
United States	The West Clinic	Memphis	Tennessee
United States	Medical College of Wisconsin-FMLH East Neoplastic Diseases and Related Disorders	Milwaukee	Wisconsin
United States	Yale University	New Haven	Connecticut
United States	Louisiana State University	New Orleans	Louisiana
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	Southfield Oncology Institute, Inc.	Southfield	Michigan
United States	Highlands Oncology Group	Springdale	Arkansas
United States	St. Louis Center for Clinical Research	St. Louis	Missouri
United States	SUNY Upstate Medical University	Syracuse	New York
United States	San Diego Cancer Research Institute	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharma USA

Country where clinical trial is conducted

United States,